Opioid Withdrawal
Conditions
Keywords
detoxification, agonist taper, methadone step down, buprenorphine step down, opioid withdrawal syndrome
Brief summary
The purpose of this Phase 3 open-label treatment study is to evaluate the safety and effectiveness of lofexidine at a clinically relevant dose to alleviate symptoms of acute withdrawal from any opioid, including methadone and buprenorphine. This study will take place in a variety of clinical scenarios, both in-clinic and outpatient settings.
Detailed description
Eligible subjects (person seeking treatment for partial or total opioid withdrawal) enrolled in this study are required to take lofexidine for a minimum of 7 days.
Interventions
DRUGLofexidine
All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
Sponsors
National Institute on Drug Abuse (NIDA)
USWM, LLC (dba US WorldMeds)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or Female at least 18 years of age * Must be able to verbalize understanding of the consent form, able to provide written informed consent, and verbalize willingness to complete study procedures * Must have current dependence, according to the Mini International Neuropsychiatric Interview (M.I.N.I.), on any opioid (including methadone and buprenorphine maintenance treatment) * Must be seeking treatment for partial or total withdrawal from current opioid and expected, as determined by the Principal Investigator, to benefit from lofexidine treatment for at least 7 days at clinically relevant doses. This can include a variety of clinical situations where opioid withdrawal illness is likely to occur including abrupt and total withdrawal (including from methadone and buprenorphine), agonist-assisted total withdrawal, dose reduction of maintenance treatment (e.g., methadone, buprenorphine) and transition from an opioid agonist to naltrexone or buprenorphine maintenance * Must have Urine toxicology screen result of positive for opioid(s) relevant to the subject's withdrawal treatment goal * If female and of childbearing potential, subject must agree to use of one of the following methods of birth control including oral contraceptives, patch, barrier (diaphragm, sponge or condom) plus spermicidal preparations, intrauterine contraceptive system, levonorgestrel implant, medroxyprogesterone acetate contraceptive injection, complete abstinence from sexual intercourse, hormonal vaginal contraceptive ring or surgical sterilization or partner sterile (with documented proof)
Exclusion criteria
* Female subject who is pregnant or lactating * History of very serious medical illness not under control including, but not limited to, active self-reported acquired immune deficiency syndrome (AIDS) or self-reported human immunodeficiency virus (HIV) positive status and taking retroviral medications currently or within the past 4 weeks and/or having an unstable psychiatric condition. These conditions will be determined at Screening by medical history, physical examination, 12 lead electrocardiogram (duplicate), clinical laboratory tests for infectious diseases, and a tuberculin test * Current dependence (based on the M.I.N.I.) on any psychoactive substance (excluding caffeine, nicotine, and the subject's current opioid-dependence agent, which can include methadone and buprenorphine, for example, in agonist-maintained subjects) that requires detoxification or dose reduction as part of the pre-defined individual subject withdrawal treatment goal * Have participated in an investigational drug study within the past 30 days * Have a history of lofexidine exposure in a prior clinical trial or otherwise * Have an abnormal cardiovascular exam at screening * Any subject that requires tricyclic antidepressants, which may reduce the efficacy of imidazoline derivatives and/or beta-receptor blockers, to avoid the risk of excessive bradycardia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Occurrence of Treatment Emergent Adverse Events (TEAEs) | Days 1-14 | Subjects with at least 1 TEAE occurring on days 1-14. |
| Overall Occurrence of Serious Treatment Emergent Adverse Events (Serious TEAEs) | Days 1-14 | — |
| Overall Treatment Emergent Adverse Events (TEAEs) by Severity | Days 1-14 | — |
| Occurrence of Per Protocol Adverse Events of Special Interest (AESI) | Day 1 to Day 14 | — |
| Occurrence of Adverse Events (AEs) Not Related to Opioid Withdrawal | Day 1 to Day 14 | — |
| Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 1 to Day 14 | Baseline vital signs were defined by the assessment value at screening when subjects were not experiencing opioid withdrawal to reduce the potential for variability from the effects of different states of withdrawal that may have been present before dosing on Day 1. Overall screening values are captured in the column Inpatient: Pre 8AM; these values were recorded at various times for each participant during the screening visit, not necessarily at 8AM. Serial vital sign assessments required for inpatient visits on days 1-3, either inpatient or outpatient for days 4-7, and outpatient only for days 8-14. Day 14 only required pre-dose vital signs measurement. Day 1 Change, Pre 8AM was prior to the first dose. |
| Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 1 to Day 14 | Baseline vital signs were defined by the assessment value at screening when subjects were not experiencing opioid withdrawal to reduce the potential for variability from the effects of different states of withdrawal that may have been present before dosing on Day 1. Overall screening values are captured in the column Inpatient: Pre 8AM; these values were recorded at various times for each participant during the screening visit, not necessarily at 8AM. Serial vital sign assessments required for inpatient visits on days 1-3, either inpatient or outpatient for days 4-7, and outpatient only for days 8-14. Day 14 only required pre-dose vital signs measurement. Day 1 Change, Pre 8AM was prior to the first dose. |
| Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 1 to Day 14 | Baseline vital signs were defined by the assessment value at screening when subjects were not experiencing opioid withdrawal to reduce the potential for variability from the effects of different states of withdrawal that may have been present before dosing on Day 1. Overall screening values are captured in the column Inpatient: Pre 8AM; these values were recorded at various times for each participant during the screening visit, not necessarily at 8AM. Serial vital sign assessments required for inpatient visits on days 1-3, either inpatient or outpatient for days 4-7, and outpatient only for days 8-14. Day 14 only required pre-dose vital signs measurement. Day 1 Change, Pre 8AM was prior to the first dose. |
| Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 1 to Day 14 | Baseline vital signs were defined by the assessment value at screening when subjects were not experiencing opioid withdrawal to reduce the potential for variability from the effects of different states of withdrawal that may have been present before dosing on Day 1. Overall screening values are captured in the column Inpatient: Pre 8AM; these values were recorded at various times for each participant during the screening visit, not necessarily at 8AM. Serial vital sign assessments required for inpatient visits on days 1-3, either inpatient or outpatient for days 4-7, and outpatient only for days 8-14. Day 14 only required pre-dose vital signs measurement. Day 1 Change, Pre 8AM was prior to the first dose. |
| Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 1 to Day 14 | Baseline vital signs were defined by the assessment value at screening when subjects were not experiencing opioid withdrawal to reduce the potential for variability from the effects of different states of withdrawal that may have been present before dosing on Day 1. Overall screening values are captured in the column Inpatient: Pre 8AM; these values were recorded at various times for each participant during the screening visit, not necessarily at 8AM. Serial vital sign assessments required for inpatient visits on days 1-3, either inpatient or outpatient for days 4-7, and outpatient only for days 8-14. Day 14 only required pre-dose vital signs measurement. Day 1 Change, Pre 8AM was prior to the first dose. |
| Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 1 to Day 14 | Baseline vital signs were defined by the assessment value at screening when subjects were not experiencing opioid withdrawal to reduce the potential for variability from the effects of different states of withdrawal that may have been present before dosing on Day 1. Overall screening values are captured in the column Inpatient: Pre 8AM; these values were recorded at various times for each participant during the screening visit, not necessarily at 8AM. Serial vital sign assessments required for inpatient visits on days 1-3, either inpatient or outpatient for days 4-7, and outpatient only for days 8-14. Day 14 only required pre-dose vital signs measurement. Day 1 Change, Pre 8AM was prior to the first dose. |
| Columbia Suicide Severity Rating Scale Questionnaire (C-SSRS): Suicidal Ideation and Behavior Numbers | Day 1 to Day 14 | The C-SSRS measures both suicidal ideation and suicidal behavior and will be completed to assess lifetime suicidality before first dose of study drug, 3.5 hours after first daily dose of study drug on in-clinic treatment days, and then once a day before dosing during outpatient treatment days. C-SSRS will also be assessed at end of study/discontinuation. |
| Clinical Laboratory Test Change From Baseline: Hematology | Day 1 to Day 14 | Hematology Parameters with Shifts in ≥3% of Subjects from Screening to End of Study |
| Clinical Laboratory Test Change From Baseline: Chemistry | Day 1 to Day 14 | Chemistry Parameters with Shifts in ≥3% of Subjects from Screening to End of Study |
| Clinical Laboratory Test Change From Baseline: Urinalysis | Day 1 to Day 7 | — |
| Safety Electrocardiograms (ECG) Evaluation Shift From Baseline to Post Dose and End of Study | Day 1 and Day 14 | For each 12-lead ECG obtained during the study, the investigator made an overall interpretation of the ECG (normal, abnormal NCS, and abnormal CS). Shifts from normal at baseline to abnormal NCS and abnormal CS at the end of study predose and postdose assessments were summarized. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OL: Lofexidine HCl Lofexidine: All enrolled subjects will take lofexidine orally, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
Subjects are given the option to receive lofexidine tablets for a minimum of 7 days, and up to 14 days if requested. | 286 |
| Total | 286 |
Baseline characteristics
| Characteristic | OL: Lofexidine HCl |
|---|---|
| Age, Continuous | 37.5 years STANDARD_DEVIATION 10.32 |
| BMI (kg/m^2) | 26.1 kg/m^2 STANDARD_DEVIATION 5.43 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 44 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 242 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Height (cm) | 173.2 cm STANDARD_DEVIATION 9.99 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 62 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 218 Participants |
| Sex: Female, Male Female | 98 Participants |
| Sex: Female, Male Male | 188 Participants |
| Weight (kg) | 78.4 kg STANDARD_DEVIATION 17.96 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 286 |
| other Total, other adverse events | 270 / 286 |
| serious Total, serious adverse events | 2 / 286 |
Outcome results
Primary
Clinical Laboratory Test Change From Baseline: Chemistry
Chemistry Parameters with Shifts in ≥3% of Subjects from Screening to End of Study
Time frame: Day 1 to Day 14
Population: Participants Analyzed does not match the Participant Flow as a result of missing data for some participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Creatinine (mg/dL) : Below (Baseline) | 29 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Alanine aminotransferase (U/L) : Normal (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Chloride (mEq/L) : Below (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Creatinine (mg/dL) : Normal (Baseline) | 8 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Phosphate (mg/dL) : Above (Baseline) | 1 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Potassium (mEq/L) : Above (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Creatinine (mg/dL) : Above (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Gamma-glutamyl transferase (U/L) : Normal (Baseline) | 2 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Potassium (mEq/L) : Normal (Baseline) | 2 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Cholesterol (mg/dL) : Below (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Thyroid Stimulating Hormone-3rd Generation (TSH Thyrotropin)(mU/L) : Below (Baseline) | 11 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Potassium (mEq/L) : Below (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Cholesterol (mg/dL) : Normal (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Phosphate (mg/dL) : Normal (Baseline) | 6 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Sodium (mEq/L) : Above (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Cholesterol (mg/dL) : Above (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Gamma-glutamyl transferase (U/L) : Above (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Sodium (mEq/L) : Normal (Baseline) | 3 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Triglycerides (mg/dL) : Below (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Aspartate Aminotransferase (U/L) : Below (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Sodium (mEq/L) : Below (Baseline) | 3 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Triglycerides (mg/dL) : Normal (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Phosphate (mg/dL) : Below (Baseline) | 1 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Calcium (mg/dL) : Above (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Triglycerides (mg/dL) : Above (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Alkaline phosphatase (U/L) : Below (Baseline) | 6 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Calcium (mg/dL) : Normal (Baseline) | 7 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Calcium (mg/dL) : Below (Baseline) | 1 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Thyroid Stimulating Hormone-3rd Generation (TSH Thyrotropin)(mU/L) : Above (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Glucose (mg/dL) : Above (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Alkaline phosphatase (U/L) : Normal (Baseline) | 9 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Protein (g/dL) : Above (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Glucose (mg/dL) : Normal (Baseline) | 1 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Alkaline phosphatase (U/L) : Above (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Aspartate Aminotransferase (U/L) : Normal (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Glucose (mg/dL) : Below (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Lactate dehydrogenase (U/L) : Below (Baseline) | 2 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Thyroid Stimulating Hormone-3rd Generation (TSH Thyrotropin)(mU/L) : Normal (Baseline) | 16 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Carbon dioxide (bicarbonate) (mEq/L) : Above (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Lactate dehydrogenase (U/L) : Normal (Baseline) | 3 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Protein (g/dL) : Normal (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Alanine aminotransferase (U/L) : Below (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Lactate dehydrogenase (U/L) : Above (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Aspartate Aminotransferase (U/L) : Above (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Carbon dioxide (bicarbonate) (mEq/L) : Normal (Baseline) | 3 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Blood urea nitrogen (mg/dL) : Below (Baseline) | 9 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Alanine aminotransferase (U/L) : Above (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Carbon dioxide (bicarbonate) (mEq/L) : Below (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Blood urea nitrogen (mg/dL) : Normal (Baseline) | 28 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Protein (g/dL) : Below (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Chloride (mEq/L) : Above (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Blood urea nitrogen (mg/dL) : Above (Baseline) | 1 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Gamma-glutamyl transferase (U/L) : Below (Baseline) | 9 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Chemistry | Chloride (mEq/L) : Normal (Baseline) | 3 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Carbon dioxide (bicarbonate) (mEq/L) : Normal (Baseline) | 134 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Alanine aminotransferase (U/L) : Below (Baseline) | 0 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Alanine aminotransferase (U/L) : Normal (Baseline) | 153 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Alanine aminotransferase (U/L) : Above (Baseline) | 12 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Aspartate Aminotransferase (U/L) : Below (Baseline) | 0 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Aspartate Aminotransferase (U/L) : Normal (Baseline) | 164 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Aspartate Aminotransferase (U/L) : Above (Baseline) | 16 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Gamma-glutamyl transferase (U/L) : Below (Baseline) | 13 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Gamma-glutamyl transferase (U/L) : Normal (Baseline) | 139 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Gamma-glutamyl transferase (U/L) : Above (Baseline) | 6 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Alkaline phosphatase (U/L) : Below (Baseline) | 3 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Alkaline phosphatase (U/L) : Normal (Baseline) | 170 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Alkaline phosphatase (U/L) : Above (Baseline) | 5 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Lactate dehydrogenase (U/L) : Below (Baseline) | 0 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Lactate dehydrogenase (U/L) : Normal (Baseline) | 164 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Lactate dehydrogenase (U/L) : Above (Baseline) | 19 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Blood urea nitrogen (mg/dL) : Below (Baseline) | 28 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Blood urea nitrogen (mg/dL) : Normal (Baseline) | 127 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Blood urea nitrogen (mg/dL) : Above (Baseline) | 4 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Creatinine (mg/dL) : Below (Baseline) | 17 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Creatinine (mg/dL) : Normal (Baseline) | 147 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Creatinine (mg/dL) : Above (Baseline) | 0 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Cholesterol (mg/dL) : Below (Baseline) | 0 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Cholesterol (mg/dL) : Normal (Baseline) | 153 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Cholesterol (mg/dL) : Above (Baseline) | 13 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Triglycerides (mg/dL) : Below (Baseline) | 0 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Triglycerides (mg/dL) : Normal (Baseline) | 107 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Triglycerides (mg/dL) : Above (Baseline) | 18 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Calcium (mg/dL) : Below (Baseline) | 9 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Calcium (mg/dL) : Normal (Baseline) | 182 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Calcium (mg/dL) : Above (Baseline) | 2 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Sodium (mEq/L) : Below (Baseline) | 6 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Sodium (mEq/L) : Normal (Baseline) | 187 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Sodium (mEq/L) : Above (Baseline) | 0 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Potassium (mEq/L) : Below (Baseline) | 2 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Potassium (mEq/L) : Normal (Baseline) | 183 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Potassium (mEq/L) : Above (Baseline) | 6 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Chloride (mEq/L) : Below (Baseline) | 5 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Chloride (mEq/L) : Normal (Baseline) | 190 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Chloride (mEq/L) : Above (Baseline) | 0 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Carbon dioxide (bicarbonate) (mEq/L) : Below (Baseline) | 0 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Carbon dioxide (bicarbonate) (mEq/L) : Above (Baseline) | 52 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Glucose (mg/dL) : Below (Baseline) | 5 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Glucose (mg/dL) : Normal (Baseline) | 130 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Glucose (mg/dL) : Above (Baseline) | 19 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Phosphate (mg/dL) : Below (Baseline) | 4 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Phosphate (mg/dL) : Normal (Baseline) | 138 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Phosphate (mg/dL) : Above (Baseline) | 26 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Protein (g/dL) : Below (Baseline) | 1 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Protein (g/dL) : Normal (Baseline) | 190 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Protein (g/dL) : Above (Baseline) | 6 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Thyroid Stimulating Hormone-3rd Generation (TSH Thyrotropin)(mU/L) : Below (Baseline) | 18 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Thyroid Stimulating Hormone-3rd Generation (TSH Thyrotropin)(mU/L) : Normal (Baseline) | 149 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Chemistry | Thyroid Stimulating Hormone-3rd Generation (TSH Thyrotropin)(mU/L) : Above (Baseline) | 6 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Creatinine (mg/dL) : Below (Baseline) | 0 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Alanine aminotransferase (U/L) : Normal (Baseline) | 17 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Chloride (mEq/L) : Below (Baseline) | 0 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Blood urea nitrogen (mg/dL) : Above (Baseline) | 1 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Protein (g/dL) : Below (Baseline) | 0 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Chloride (mEq/L) : Normal (Baseline) | 5 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Blood urea nitrogen (mg/dL) : Normal (Baseline) | 5 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Aspartate Aminotransferase (U/L) : Normal (Baseline) | 10 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Chloride (mEq/L) : Above (Baseline) | 1 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Blood urea nitrogen (mg/dL) : Below (Baseline) | 1 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Thyroid Stimulating Hormone-3rd Generation (TSH Thyrotropin)(mU/L) : Above (Baseline) | 1 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Carbon dioxide (bicarbonate) (mEq/L) : Below (Baseline) | 0 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Lactate dehydrogenase (U/L) : Above (Baseline) | 9 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Lactate dehydrogenase (U/L) : Normal (Baseline) | 7 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Carbon dioxide (bicarbonate) (mEq/L) : Normal (Baseline) | 7 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Lactate dehydrogenase (U/L) : Below (Baseline) | 0 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Protein (g/dL) : Normal (Baseline) | 4 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Carbon dioxide (bicarbonate) (mEq/L) : Above (Baseline) | 8 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Alkaline phosphatase (U/L) : Above (Baseline) | 8 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Aspartate Aminotransferase (U/L) : Below (Baseline) | 0 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Glucose (mg/dL) : Below (Baseline) | 0 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Alkaline phosphatase (U/L) : Normal (Baseline) | 3 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Thyroid Stimulating Hormone-3rd Generation (TSH Thyrotropin)(mU/L) : Normal (Baseline) | 3 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Glucose (mg/dL) : Normal (Baseline) | 35 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Alkaline phosphatase (U/L) : Below (Baseline) | 0 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Protein (g/dL) : Above (Baseline) | 3 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Glucose (mg/dL) : Above (Baseline) | 14 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Gamma-glutamyl transferase (U/L) : Above (Baseline) | 24 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Alanine aminotransferase (U/L) : Above (Baseline) | 22 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Calcium (mg/dL) : Below (Baseline) | 0 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Triglycerides (mg/dL) : Above (Baseline) | 39 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Phosphate (mg/dL) : Below (Baseline) | 0 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Calcium (mg/dL) : Normal (Baseline) | 3 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Triglycerides (mg/dL) : Normal (Baseline) | 40 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Gamma-glutamyl transferase (U/L) : Normal (Baseline) | 11 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Calcium (mg/dL) : Above (Baseline) | 0 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Triglycerides (mg/dL) : Below (Baseline) | 0 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Alanine aminotransferase (U/L) : Below (Baseline) | 0 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Sodium (mEq/L) : Below (Baseline) | 0 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Cholesterol (mg/dL) : Above (Baseline) | 20 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Phosphate (mg/dL) : Normal (Baseline) | 22 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Sodium (mEq/L) : Normal (Baseline) | 5 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Cholesterol (mg/dL) : Normal (Baseline) | 18 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Gamma-glutamyl transferase (U/L) : Below (Baseline) | 0 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Sodium (mEq/L) : Above (Baseline) | 0 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Cholesterol (mg/dL) : Below (Baseline) | 0 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Thyroid Stimulating Hormone-3rd Generation (TSH Thyrotropin)(mU/L) : Below (Baseline) | 0 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Potassium (mEq/L) : Below (Baseline) | 0 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Creatinine (mg/dL) : Above (Baseline) | 1 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Phosphate (mg/dL) : Above (Baseline) | 6 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Potassium (mEq/L) : Normal (Baseline) | 11 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Creatinine (mg/dL) : Normal (Baseline) | 2 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Aspartate Aminotransferase (U/L) : Above (Baseline) | 14 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Chemistry | Potassium (mEq/L) : Above (Baseline) | 0 Participants |
Primary
Clinical Laboratory Test Change From Baseline: Hematology
Hematology Parameters with Shifts in ≥3% of Subjects from Screening to End of Study
Time frame: Day 1 to Day 14
Population: The number of participants analyzed for each parameter differs from the overall number of participants analyzed as a result of missing data for some participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Hematology | Mean corpuscular volume (fL) : Above (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Hematology | Platelet count (x10^9/L) : Below (Baseline) | 11 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Hematology | Monocytes/Leukocytes (%) : Normal (Baseline) | 1 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Hematology | Leukocytes (x10^9/L) : Below (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Hematology | Hemoglobin (g/dL) : Normal (Baseline) | 8 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Hematology | Monocytes/Leukocytes (%) : Below (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Hematology | Leukocytes (x10^9/L) : Normal (Baseline) | 2 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Hematology | Hemoglobin (g/dL) : Below (Baseline) | 25 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Hematology | Lymphocytes, absolute (x10^9/L) : Above (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Hematology | Leukocytes (x10^9/L) : Above (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Hematology | Platelet count (x10^9/L) : Normal (Baseline) | 4 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Hematology | Lymphocytes, absolute (x10^9/L) : Normal (Baseline) | 3 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Hematology | Neutrophils/Leukocytes (%) : Below (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Hematology | Activated Partial Thromboplastin Time (seconds) : Below (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Hematology | Lymphocytes, absolute (x10^9/L) : Below (Baseline) | 1 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Hematology | Neutrophils/Leukocytes (%) : Normal (Baseline) | 2 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Hematology | Eosinophils/Leukocytes (%) : Above (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Hematology | Lymphocytes/Leukocytes (%) : Above (Baseline) | 1 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Hematology | Neutrophils/Leukocytes (%) : Above (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Hematology | Platelet count (x10^9/L) : Above (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Hematology | Lymphocytes/Leukocytes (%) : Normal (Baseline) | 32 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Hematology | Neutrophils (x10^9/L) : Below (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Hematology | Hematocrit (%) : Below (Baseline) | 11 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Hematology | Lymphocytes/Leukocytes (%) : Below (Baseline) | 23 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Hematology | Neutrophils (x10^9/L) : Normal (Baseline) | 1 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Hematology | Eosinophils/Leukocytes (%) : Normal (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Hematology | Neutrophils (x10^9/L) : Above (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Hematology | Erythrocytes (x10^12/L) : Below (Baseline) | 14 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Hematology | Activated Partial Thromboplastin Time (seconds) : Above (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Hematology | Eosinophils/Leukocytes (%) : Below (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Hematology | Erythrocytes (x10^12/L) : Normal (Baseline) | 11 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Hematology | Prothrombin time (seconds) : Above (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Hematology | Eosinophils absolute (x10^9/L) : Above (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Hematology | Erythrocytes (x10^12/L) : Above (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Hematology | Hematocrit (%) : Normal (Baseline) | 6 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Hematology | Eosinophils absolute (x10^9/L) : Normal (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Hematology | Erythrocytes distribution width (%) : Below (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Hematology | Activated Partial Thromboplastin Time (seconds) : Normal (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Hematology | Eosinophils absolute (x10^9/L) : Below (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Hematology | Erythrocytes distribution width (%) : Normal (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Hematology | Prothrombin time (seconds) : Normal (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Hematology | Monocytes (x10^9/L) : Above (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Hematology | Erythrocytes distribution width (%) : Above (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Hematology | Hematocrit (%) : Above (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Hematology | Monocytes (x10^9/L) : Normal (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Hematology | Mean corpuscular volume (fL) : Below (Baseline) | 4 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Hematology | Hemoglobin (g/dL) : Above (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Hematology | Monocytes (x10^9/L) : Below (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Hematology | Mean corpuscular volume (fL) : Normal (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Hematology | Prothrombin time (seconds) : Below (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Hematology | Monocytes/Leukocytes (%) : Above (Baseline) | 0 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Hematology | Eosinophils/Leukocytes (%) : Above (Baseline) | 31 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Hematology | Hemoglobin (g/dL) : Below (Baseline) | 27 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Hematology | Hemoglobin (g/dL) : Normal (Baseline) | 124 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Hematology | Hemoglobin (g/dL) : Above (Baseline) | 1 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Hematology | Hematocrit (%) : Below (Baseline) | 23 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Hematology | Hematocrit (%) : Normal (Baseline) | 120 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Hematology | Hematocrit (%) : Above (Baseline) | 10 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Hematology | Platelet count (x10^9/L) : Below (Baseline) | 0 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Hematology | Platelet count (x10^9/L) : Normal (Baseline) | 166 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Hematology | Platelet count (x10^9/L) : Above (Baseline) | 4 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Hematology | Erythrocytes (x10^12/L) : Below (Baseline) | 20 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Hematology | Erythrocytes (x10^12/L) : Normal (Baseline) | 122 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Hematology | Erythrocytes (x10^12/L) : Above (Baseline) | 8 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Hematology | Erythrocytes distribution width (%) : Below (Baseline) | 0 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Hematology | Erythrocytes distribution width (%) : Normal (Baseline) | 150 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Hematology | Erythrocytes distribution width (%) : Above (Baseline) | 8 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Hematology | Mean corpuscular volume (fL) : Below (Baseline) | 2 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Hematology | Mean corpuscular volume (fL) : Normal (Baseline) | 173 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Hematology | Mean corpuscular volume (fL) : Above (Baseline) | 4 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Hematology | Leukocytes (x10^9/L) : Below (Baseline) | 2 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Hematology | Leukocytes (x10^9/L) : Normal (Baseline) | 167 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Hematology | Leukocytes (x10^9/L) : Above (Baseline) | 4 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Hematology | Neutrophils/Leukocytes (%) : Below (Baseline) | 4 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Hematology | Neutrophils/Leukocytes (%) : Normal (Baseline) | 163 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Hematology | Neutrophils/Leukocytes (%) : Above (Baseline) | 8 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Hematology | Neutrophils (x10^9/L) : Below (Baseline) | 0 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Hematology | Neutrophils (x10^9/L) : Normal (Baseline) | 182 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Hematology | Neutrophils (x10^9/L) : Above (Baseline) | 3 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Hematology | Lymphocytes/Leukocytes (%) : Below (Baseline) | 15 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Hematology | Lymphocytes/Leukocytes (%) : Normal (Baseline) | 103 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Hematology | Lymphocytes/Leukocytes (%) : Above (Baseline) | 12 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Hematology | Lymphocytes, absolute (x10^9/L) : Below (Baseline) | 2 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Hematology | Lymphocytes, absolute (x10^9/L) : Normal (Baseline) | 192 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Hematology | Lymphocytes, absolute (x10^9/L) : Above (Baseline) | 1 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Hematology | Monocytes/Leukocytes (%) : Below (Baseline) | 0 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Hematology | Monocytes/Leukocytes (%) : Normal (Baseline) | 159 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Hematology | Monocytes/Leukocytes (%) : Above (Baseline) | 17 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Hematology | Monocytes (x10^9/L) : Below (Baseline) | 0 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Hematology | Monocytes (x10^9/L) : Normal (Baseline) | 192 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Hematology | Monocytes (x10^9/L) : Above (Baseline) | 2 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Hematology | Eosinophils absolute (x10^9/L) : Below (Baseline) | 0 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Hematology | Eosinophils absolute (x10^9/L) : Normal (Baseline) | 176 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Hematology | Eosinophils absolute (x10^9/L) : Above (Baseline) | 10 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Hematology | Eosinophils/Leukocytes (%) : Below (Baseline) | 0 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Hematology | Eosinophils/Leukocytes (%) : Normal (Baseline) | 140 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Hematology | Prothrombin time (seconds) : Below (Baseline) | 0 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Hematology | Prothrombin time (seconds) : Normal (Baseline) | 154 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Hematology | Prothrombin time (seconds) : Above (Baseline) | 17 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Hematology | Activated Partial Thromboplastin Time (seconds) : Below (Baseline) | 1 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Hematology | Activated Partial Thromboplastin Time (seconds) : Normal (Baseline) | 154 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Hematology | Activated Partial Thromboplastin Time (seconds) : Above (Baseline) | 19 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Hematology | Mean corpuscular volume (fL) : Above (Baseline) | 13 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Hematology | Prothrombin time (seconds) : Below (Baseline) | 0 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Hematology | Monocytes/Leukocytes (%) : Normal (Baseline) | 19 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Hematology | Mean corpuscular volume (fL) : Normal (Baseline) | 6 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Hematology | Hematocrit (%) : Normal (Baseline) | 20 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Hematology | Monocytes/Leukocytes (%) : Above (Baseline) | 6 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Hematology | Mean corpuscular volume (fL) : Below (Baseline) | 0 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Hematology | Activated Partial Thromboplastin Time (seconds) : Above (Baseline) | 18 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Hematology | Monocytes (x10^9/L) : Below (Baseline) | 0 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Hematology | Erythrocytes distribution width (%) : Above (Baseline) | 22 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Hematology | Prothrombin time (seconds) : Normal (Baseline) | 20 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Hematology | Monocytes (x10^9/L) : Normal (Baseline) | 7 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Hematology | Erythrocytes distribution width (%) : Normal (Baseline) | 22 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Hematology | Hematocrit (%) : Below (Baseline) | 0 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Hematology | Monocytes (x10^9/L) : Above (Baseline) | 1 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Hematology | Erythrocytes distribution width (%) : Below (Baseline) | 0 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Hematology | Activated Partial Thromboplastin Time (seconds) : Normal (Baseline) | 13 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Hematology | Eosinophils absolute (x10^9/L) : Below (Baseline) | 0 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Hematology | Erythrocytes (x10^12/L) : Above (Baseline) | 11 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Hematology | Prothrombin time (seconds) : Above (Baseline) | 14 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Hematology | Eosinophils absolute (x10^9/L) : Normal (Baseline) | 9 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Hematology | Erythrocytes (x10^12/L) : Normal (Baseline) | 16 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Hematology | Hemoglobin (g/dL) : Above (Baseline) | 9 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Hematology | Eosinophils absolute (x10^9/L) : Above (Baseline) | 7 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Hematology | Erythrocytes (x10^12/L) : Below (Baseline) | 0 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Hematology | Hemoglobin (g/dL) : Below (Baseline) | 0 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Hematology | Eosinophils/Leukocytes (%) : Below (Baseline) | 0 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Hematology | Neutrophils (x10^9/L) : Normal (Baseline) | 13 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Hematology | Platelet count (x10^9/L) : Above (Baseline) | 2 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Hematology | Neutrophils (x10^9/L) : Above (Baseline) | 3 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Hematology | Neutrophils (x10^9/L) : Below (Baseline) | 0 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Hematology | Activated Partial Thromboplastin Time (seconds) : Below (Baseline) | 0 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Hematology | Lymphocytes/Leukocytes (%) : Below (Baseline) | 1 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Hematology | Neutrophils/Leukocytes (%) : Above (Baseline) | 6 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Hematology | Eosinophils/Leukocytes (%) : Normal (Baseline) | 12 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Hematology | Lymphocytes/Leukocytes (%) : Normal (Baseline) | 10 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Hematology | Neutrophils/Leukocytes (%) : Normal (Baseline) | 19 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Hematology | Platelet count (x10^9/L) : Normal (Baseline) | 10 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Hematology | Lymphocytes/Leukocytes (%) : Above (Baseline) | 5 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Hematology | Neutrophils/Leukocytes (%) : Below (Baseline) | 0 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Hematology | Platelet count (x10^9/L) : Below (Baseline) | 0 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Hematology | Lymphocytes, absolute (x10^9/L) : Below (Baseline) | 0 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Hematology | Leukocytes (x10^9/L) : Above (Baseline) | 4 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Hematology | Eosinophils/Leukocytes (%) : Above (Baseline) | 19 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Hematology | Lymphocytes, absolute (x10^9/L) : Normal (Baseline) | 2 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Hematology | Leukocytes (x10^9/L) : Normal (Baseline) | 23 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Hematology | Hematocrit (%) : Above (Baseline) | 12 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Hematology | Lymphocytes, absolute (x10^9/L) : Above (Baseline) | 1 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Hematology | Leukocytes (x10^9/L) : Below (Baseline) | 0 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Hematology | Hemoglobin (g/dL) : Normal (Baseline) | 8 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Hematology | Monocytes/Leukocytes (%) : Below (Baseline) | 0 Participants |
Primary
Clinical Laboratory Test Change From Baseline: Urinalysis
Time frame: Day 1 to Day 7
Population: Participants Analyzed does not match the Participant Flow as a result of missing data for some participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Urinalysis | Specific Gravity : Above (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Urinalysis | pH : Above (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Urinalysis | Leukocytes (/HPF) : Normal (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Urinalysis | pH : Normal (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Urinalysis | Erythrocytes (/HPF) : Normal (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Urinalysis | Leukocytes (/HPF) : Above (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Urinalysis | pH : Below (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Urinalysis | Erythrocytes (/HPF) : Above (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Urinalysis | Specific Gravity : Below (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Urinalysis | Leukocytes (/HPF) : Below (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Urinalysis | Erythrocytes (/HPF) : Below (Baseline) | 0 Participants |
| OL: Lofexidine HCl | Clinical Laboratory Test Change From Baseline: Urinalysis | Specific Gravity : Normal (Baseline) | 0 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Urinalysis | Leukocytes (/HPF) : Below (Baseline) | 0 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Urinalysis | Specific Gravity : Above (Baseline) | 13 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Urinalysis | Erythrocytes (/HPF) : Above (Baseline) | 28 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Urinalysis | pH : Below (Baseline) | 0 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Urinalysis | Erythrocytes (/HPF) : Below (Baseline) | 0 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Urinalysis | pH : Normal (Baseline) | 204 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Urinalysis | pH : Above (Baseline) | 2 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Urinalysis | Specific Gravity : Normal (Baseline) | 188 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Urinalysis | Leukocytes (/HPF) : Normal (Baseline) | 175 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Urinalysis | Leukocytes (/HPF) : Above (Baseline) | 13 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Urinalysis | Erythrocytes (/HPF) : Normal (Baseline) | 136 Participants |
| Inpatient: 3.5 hr Post 8AM | Clinical Laboratory Test Change From Baseline: Urinalysis | Specific Gravity : Below (Baseline) | 2 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Urinalysis | pH : Above (Baseline) | 0 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Urinalysis | Erythrocytes (/HPF) : Below (Baseline) | 0 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Urinalysis | Erythrocytes (/HPF) : Normal (Baseline) | 30 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Urinalysis | Erythrocytes (/HPF) : Above (Baseline) | 13 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Urinalysis | Leukocytes (/HPF) : Below (Baseline) | 0 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Urinalysis | Leukocytes (/HPF) : Normal (Baseline) | 15 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Urinalysis | Leukocytes (/HPF) : Above (Baseline) | 4 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Urinalysis | Specific Gravity : Below (Baseline) | 0 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Urinalysis | Specific Gravity : Normal (Baseline) | 3 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Urinalysis | Specific Gravity : Above (Baseline) | 1 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Urinalysis | pH : Below (Baseline) | 0 Participants |
| Inpatient: Pre 1PM | Clinical Laboratory Test Change From Baseline: Urinalysis | pH : Normal (Baseline) | 1 Participants |
Primary
Columbia Suicide Severity Rating Scale Questionnaire (C-SSRS): Suicidal Ideation and Behavior Numbers
The C-SSRS measures both suicidal ideation and suicidal behavior and will be completed to assess lifetime suicidality before first dose of study drug, 3.5 hours after first daily dose of study drug on in-clinic treatment days, and then once a day before dosing during outpatient treatment days. C-SSRS will also be assessed at end of study/discontinuation.
Time frame: Day 1 to Day 14
Population: Suicidality: The number and percentage of subjects reporting any suicidal ideation OR behavior throughout the assessment period, including baseline.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| OL: Lofexidine HCl | Columbia Suicide Severity Rating Scale Questionnaire (C-SSRS): Suicidal Ideation and Behavior Numbers | Suicidality | 30 Participants |
| OL: Lofexidine HCl | Columbia Suicide Severity Rating Scale Questionnaire (C-SSRS): Suicidal Ideation and Behavior Numbers | Suicidal ideation | 27 Participants |
| OL: Lofexidine HCl | Columbia Suicide Severity Rating Scale Questionnaire (C-SSRS): Suicidal Ideation and Behavior Numbers | Suicidal behavior | 12 Participants |
| OL: Lofexidine HCl | Columbia Suicide Severity Rating Scale Questionnaire (C-SSRS): Suicidal Ideation and Behavior Numbers | Emergence of suicidal ideation | 2 Participants |
| OL: Lofexidine HCl | Columbia Suicide Severity Rating Scale Questionnaire (C-SSRS): Suicidal Ideation and Behavior Numbers | Emergence of serious suicidal ideation | 0 Participants |
| OL: Lofexidine HCl | Columbia Suicide Severity Rating Scale Questionnaire (C-SSRS): Suicidal Ideation and Behavior Numbers | Worsening of suicidal ideation | 2 Participants |
| OL: Lofexidine HCl | Columbia Suicide Severity Rating Scale Questionnaire (C-SSRS): Suicidal Ideation and Behavior Numbers | Emergence of suicidal behavior | 0 Participants |
Primary
Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign
Baseline vital signs were defined by the assessment value at screening when subjects were not experiencing opioid withdrawal to reduce the potential for variability from the effects of different states of withdrawal that may have been present before dosing on Day 1. Overall screening values are captured in the column Inpatient: Pre 8AM; these values were recorded at various times for each participant during the screening visit, not necessarily at 8AM. Serial vital sign assessments required for inpatient visits on days 1-3, either inpatient or outpatient for days 4-7, and outpatient only for days 8-14. Day 14 only required pre-dose vital signs measurement. Day 1 Change, Pre 8AM was prior to the first dose.
Time frame: Day 1 to Day 14
Population: Participant Number Analyzed does not match the Participant Flow because some patient data was not captured for the visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 2 Observed | 73.8 mmHg | Standard Deviation 10.49 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 5 Observed | 73.2 mmHg | Standard Deviation 10.42 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 6 Observed | 72.2 mmHg | Standard Deviation 10.33 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 1 Observed | 78.3 mmHg | Standard Deviation 8.89 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 2 Change | -3.3 mmHg | Standard Deviation 10.73 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 4 Change | -3.2 mmHg | Standard Deviation 11.06 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 6 Change | -4.6 mmHg | Standard Deviation 9.87 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 1 Change | NA mmHg | — |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 7 Change | -3.6 mmHg | Standard Deviation 11.56 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 3 Change | -3.6 mmHg | Standard Deviation 11.6 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 5 Change | -3.8 mmHg | Standard Deviation 11.17 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 3 Observed | 73.7 mmHg | Standard Deviation 11.05 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 4 Observed | 73.9 mmHg | Standard Deviation 10.55 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 7 Observed | 72.9 mmHg | Standard Deviation 10.63 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 3 Change | -4.0 mmHg | Standard Deviation 10.97 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 4 Observed | 71.4 mmHg | Standard Deviation 10.28 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 4 Change | -5.7 mmHg | Standard Deviation 10.75 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 1 Change | -7.8 mmHg | Standard Deviation 10.78 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 7 Observed | 74.3 mmHg | Standard Deviation 9.9 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 2 Observed | 72.2 mmHg | Standard Deviation 10.89 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 6 Change | -7.0 mmHg | Standard Deviation 10.86 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 2 Change | -4.9 mmHg | Standard Deviation 11.17 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 1 Observed | 69.4 mmHg | Standard Deviation 10.95 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 6 Observed | 69.8 mmHg | Standard Deviation 10.46 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 3 Observed | 73.2 mmHg | Standard Deviation 10.59 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 5 Change | -5.4 mmHg | Standard Deviation 11.75 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 7 Change | -3.5 mmHg | Standard Deviation 10.59 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 5 Observed | 71.5 mmHg | Standard Deviation 10.25 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 7 Observed | 71.5 mmHg | Standard Deviation 11.18 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 4 Observed | 70.9 mmHg | Standard Deviation 11.11 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 3 Observed | 71.4 mmHg | Standard Deviation 10.05 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 7 Change | -4.8 mmHg | Standard Deviation 12.01 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 5 Change | -5.1 mmHg | Standard Deviation 10.59 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 5 Observed | 71.7 mmHg | Standard Deviation 10.38 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 1 Observed | 69.3 mmHg | Standard Deviation 10.34 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 6 Change | -6.0 mmHg | Standard Deviation 11.42 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 1 Change | -7.9 mmHg | Standard Deviation 9.88 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 2 Change | -5.0 mmHg | Standard Deviation 10.61 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 4 Change | -6.4 mmHg | Standard Deviation 10.48 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 6 Observed | 70.8 mmHg | Standard Deviation 10.81 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 3 Change | -5.8 mmHg | Standard Deviation 10.88 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 2 Observed | 72.2 mmHg | Standard Deviation 10.2 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 2 Observed | 73.4 mmHg | Standard Deviation 11.53 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 1 Observed | 70.8 mmHg | Standard Deviation 11.13 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 1 Change | -6.3 mmHg | Standard Deviation 11.49 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 2 Change | -3.8 mmHg | Standard Deviation 11.38 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 3 Observed | 73.0 mmHg | Standard Deviation 10.48 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 3 Change | -4.1 mmHg | Standard Deviation 10.32 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 4 Observed | 74.7 mmHg | Standard Deviation 10.39 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 4 Change | -2.6 mmHg | Standard Deviation 10.27 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 5 Observed | 72.7 mmHg | Standard Deviation 10.58 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 5 Change | -4.2 mmHg | Standard Deviation 10.38 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 6 Observed | 72.2 mmHg | Standard Deviation 10.08 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 6 Change | -4.6 mmHg | Standard Deviation 10.46 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 7 Observed | 70.2 mmHg | Standard Deviation 10.4 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 7 Change | -6.9 mmHg | Standard Deviation 10.96 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 5 Observed | 71.8 mmHg | Standard Deviation 10.14 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 1 Observed | 71.5 mmHg | Standard Deviation 10.76 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 3 Observed | 72.9 mmHg | Standard Deviation 10.64 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 5 Change | -5.0 mmHg | Standard Deviation 10.79 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 2 Observed | 73.7 mmHg | Standard Deviation 12.08 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 4 Change | -3.3 mmHg | Standard Deviation 9.74 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 1 Change | -5.7 mmHg | Standard Deviation 10.8 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 6 Change | -4.3 mmHg | Standard Deviation 10.77 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 7 Change | -7.6 mmHg | Standard Deviation 10.25 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 4 Observed | 73.7 mmHg | Standard Deviation 10.1 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 2 Change | -3.4 mmHg | Standard Deviation 12.04 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 7 Observed | 70.0 mmHg | Standard Deviation 9.09 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 6 Observed | 72.6 mmHg | Standard Deviation 11.02 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 3 Change | -4.3 mmHg | Standard Deviation 10.56 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 6 Observed | 72.8 mmHg | Standard Deviation 11.35 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 1 Change | -3.7 mmHg | Standard Deviation 12.52 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 4 Observed | 74.0 mmHg | Standard Deviation 10.95 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 2 Observed | 75.4 mmHg | Standard Deviation 11.67 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 6 Change | -4.0 mmHg | Standard Deviation 11.05 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 5 Observed | 73.1 mmHg | Standard Deviation 9.97 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 4 Change | -3.1 mmHg | Standard Deviation 11.75 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 7 Change | -4.5 mmHg | Standard Deviation 10.21 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 3 Observed | 73.2 mmHg | Standard Deviation 11.32 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 5 Change | -3.7 mmHg | Standard Deviation 10.77 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 1 Observed | 73.5 mmHg | Standard Deviation 12.18 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 7 Observed | 73.1 mmHg | Standard Deviation 9.62 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 3 Change | -4.0 mmHg | Standard Deviation 11.41 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 2 Change | -1.8 mmHg | Standard Deviation 12.19 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 5 Observed | 72.3 mmHg | Standard Deviation 10.44 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 4 Change | -3.6 mmHg | Standard Deviation 10.51 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 3 Change | -3.8 mmHg | Standard Deviation 11.37 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 3 Observed | 73.5 mmHg | Standard Deviation 11.08 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 5 Change | -4.7 mmHg | Standard Deviation 10.56 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 2 Change | -3.3 mmHg | Standard Deviation 12.11 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 6 Observed | 72.0 mmHg | Standard Deviation 11.29 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 2 Observed | 74.0 mmHg | Standard Deviation 11.44 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 6 Change | -4.9 mmHg | Standard Deviation 11.51 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 1 Change | -4.3 mmHg | Standard Deviation 12.55 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 7 Observed | 69.8 mmHg | Standard Deviation 8.04 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 1 Observed | 72.8 mmHg | Standard Deviation 12.26 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 7 Change | -7.5 mmHg | Standard Deviation 12.94 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 4 Observed | 73.4 mmHg | Standard Deviation 9.78 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 14 Change | 3.5 mmHg | Standard Deviation 9.72 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 14 Observed | 78.4 mmHg | Standard Deviation 7.81 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 13 Change | 1.3 mmHg | Standard Deviation 10.94 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 13 Observed | 77.2 mmHg | Standard Deviation 8.22 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 7 Observed | 76.1 mmHg | Standard Deviation 9.3 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 5 Change | -5.6 mmHg | Standard Deviation 11.18 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 6 Observed | 74.2 mmHg | Standard Deviation 11.25 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 5 Observed | 72.6 mmHg | Standard Deviation 9.99 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 7 Change | -2.6 mmHg | Standard Deviation 11.32 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 8 Observed | 73.5 mmHg | Standard Deviation 9.23 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 8 Change | -4.1 mmHg | Standard Deviation 10.98 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 9 Observed | 75.5 mmHg | Standard Deviation 9.38 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 9 Change | -1.7 mmHg | Standard Deviation 10.71 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 10 Observed | 74.6 mmHg | Standard Deviation 9.44 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 10 Change | -2.4 mmHg | Standard Deviation 9.31 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 11 Observed | 75.7 mmHg | Standard Deviation 10.37 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 11 Change | -0.9 mmHg | Standard Deviation 11.57 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 12 Observed | 77.3 mmHg | Standard Deviation 8.01 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 12 Change | 0.6 mmHg | Standard Deviation 10.39 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 4 Observed | 75.0 mmHg | Standard Deviation 8.57 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 6 Change | -3.9 mmHg | Standard Deviation 12.17 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 4 Change | -3.0 mmHg | Standard Deviation 10.65 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 4 Observed | 71.7 mmHg | Standard Deviation 8.53 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 5 Change | -6.0 mmHg | Standard Deviation 12.01 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 9 Change | -3.5 mmHg | Standard Deviation 12.63 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 12 Observed | 76.6 mmHg | Standard Deviation 8.26 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 7 Observed | 71.8 mmHg | Standard Deviation 8.9 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 4 Change | -6.1 mmHg | Standard Deviation 10.68 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 10 Observed | 75.8 mmHg | Standard Deviation 12.46 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 13 Observed | 77.9 mmHg | Standard Deviation 8.98 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 6 Observed | 76.8 mmHg | Standard Deviation 9.99 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 5 Observed | 72.8 mmHg | Standard Deviation 10.67 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 10 Change | -1.2 mmHg | Standard Deviation 12.34 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 12 Change | -0.5 mmHg | Standard Deviation 9.47 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 6 Change | -1.4 mmHg | Standard Deviation 12.9 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 7 Change | -7.6 mmHg | Standard Deviation 14.12 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 11 Observed | 76.3 mmHg | Standard Deviation 8.99 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 8 Observed | 73.9 mmHg | Standard Deviation 11.18 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 13 Change | 2.0 mmHg | Standard Deviation 13.71 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 8 Change | -3.5 mmHg | Standard Deviation 13.1 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 11 Change | -0.4 mmHg | Standard Deviation 10.87 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Diastolic Blood Pressure (mmHg): Vital Sign | Day 9 Observed | 74.0 mmHg | Standard Deviation 11.92 |
Primary
Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs
Baseline vital signs were defined by the assessment value at screening when subjects were not experiencing opioid withdrawal to reduce the potential for variability from the effects of different states of withdrawal that may have been present before dosing on Day 1. Overall screening values are captured in the column Inpatient: Pre 8AM; these values were recorded at various times for each participant during the screening visit, not necessarily at 8AM. Serial vital sign assessments required for inpatient visits on days 1-3, either inpatient or outpatient for days 4-7, and outpatient only for days 8-14. Day 14 only required pre-dose vital signs measurement. Day 1 Change, Pre 8AM was prior to the first dose.
Time frame: Day 1 to Day 14
Population: Participant Number Analyzed does not match the Participant Flow because some patient data was not captured for the visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 7 Change | -1.1 beats per minute (bpm) | Standard Deviation 16.86 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 3 Observed | 213 beats per minute (bpm) | Standard Deviation 70 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 6 Observed | 70.5 beats per minute (bpm) | Standard Deviation 11.24 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 1 Change | NA beats per minute (bpm) | — |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 7 Observed | 73.2 beats per minute (bpm) | Standard Deviation 13.34 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 2 Observed | 70.2 beats per minute (bpm) | Standard Deviation 12.7 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 4 Change | -5.0 beats per minute (bpm) | Standard Deviation 16.11 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 5 Change | -3.4 beats per minute (bpm) | Standard Deviation 16.28 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 3 Change | -5.0 beats per minute (bpm) | Standard Deviation 15.1 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 6 Change | -3.6 beats per minute (bpm) | Standard Deviation 14.98 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 1 Observed | 73.3 beats per minute (bpm) | Standard Deviation 10.89 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 4 Observed | 70.1 beats per minute (bpm) | Standard Deviation 13.6 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 2 Change | -4.7 beats per minute (bpm) | Standard Deviation 14.21 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 5 Observed | 70.9 beats per minute (bpm) | Standard Deviation 13.7 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 7 Observed | 73.9 beats per minute (bpm) | Standard Deviation 11.7 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 3 Change | -7.5 beats per minute (bpm) | Standard Deviation 15.52 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 4 Observed | 68.3 beats per minute (bpm) | Standard Deviation 12.46 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 6 Change | -4.1 beats per minute (bpm) | Standard Deviation 14.44 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 1 Observed | 68.8 beats per minute (bpm) | Standard Deviation 11.92 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 6 Observed | 69.8 beats per minute (bpm) | Standard Deviation 12.46 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 1 Change | -6.1 beats per minute (bpm) | Standard Deviation 12.75 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 7 Change | 0.0 beats per minute (bpm) | Standard Deviation 13.6 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 5 Change | -5.3 beats per minute (bpm) | Standard Deviation 13.57 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 2 Observed | 68.8 beats per minute (bpm) | Standard Deviation 12.36 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 5 Observed | 69.1 beats per minute (bpm) | Standard Deviation 11.03 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 2 Change | -5.9 beats per minute (bpm) | Standard Deviation 14.63 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 4 Change | -6.8 beats per minute (bpm) | Standard Deviation 15.56 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 3 Observed | 67.5 beats per minute (bpm) | Standard Deviation 12.97 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 5 Observed | 71.4 beats per minute (bpm) | Standard Deviation 11.78 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 3 Change | -6.4 beats per minute (bpm) | Standard Deviation 14.42 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 7 Change | -3.1 beats per minute (bpm) | Standard Deviation 13.15 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 1 Observed | 69.2 beats per minute (bpm) | Standard Deviation 11.08 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 7 Observed | 73.6 beats per minute (bpm) | Standard Deviation 11.55 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 2 Change | -5.4 beats per minute (bpm) | Standard Deviation 13.64 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 4 Change | -4.5 beats per minute (bpm) | Standard Deviation 15.43 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 3 Observed | 68.7 beats per minute (bpm) | Standard Deviation 11.57 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 6 Change | -3.3 beats per minute (bpm) | Standard Deviation 13.62 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 5 Change | -2.8 beats per minute (bpm) | Standard Deviation 13.92 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 1 Change | -5.7 beats per minute (bpm) | Standard Deviation 12.11 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 4 Observed | 70.6 beats per minute (bpm) | Standard Deviation 12.98 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 2 Observed | 69.4 beats per minute (bpm) | Standard Deviation 11.57 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 6 Observed | 70.6 beats per minute (bpm) | Standard Deviation 12.24 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 2 Change | -8.0 beats per minute (bpm) | Standard Deviation 14.53 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 1 Observed | 69.9 beats per minute (bpm) | Standard Deviation 12.57 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 1 Change | -4.9 beats per minute (bpm) | Standard Deviation 13.47 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 2 Observed | 66.8 beats per minute (bpm) | Standard Deviation 12.65 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 3 Observed | 66.6 beats per minute (bpm) | Standard Deviation 12.03 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 3 Change | -8.5 beats per minute (bpm) | Standard Deviation 14.77 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 4 Observed | 67.8 beats per minute (bpm) | Standard Deviation 13 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 4 Change | -7.3 beats per minute (bpm) | Standard Deviation 15.44 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 5 Observed | 69.0 beats per minute (bpm) | Standard Deviation 13.35 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 5 Change | -5.2 beats per minute (bpm) | Standard Deviation 15.23 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 6 Observed | 68.6 beats per minute (bpm) | Standard Deviation 11.43 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 6 Change | -5.3 beats per minute (bpm) | Standard Deviation 14.37 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 7 Observed | 73.0 beats per minute (bpm) | Standard Deviation 12.53 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 7 Change | -3.8 beats per minute (bpm) | Standard Deviation 12.93 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 5 Change | -5.5 beats per minute (bpm) | Standard Deviation 12.29 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 6 Observed | 69.7 beats per minute (bpm) | Standard Deviation 10.67 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 2 Observed | 68.7 beats per minute (bpm) | Standard Deviation 12.11 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 4 Observed | 70.0 beats per minute (bpm) | Standard Deviation 12.01 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 5 Observed | 68.7 beats per minute (bpm) | Standard Deviation 11.08 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 1 Observed | 70.5 beats per minute (bpm) | Standard Deviation 12.28 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 1 Change | -4.3 beats per minute (bpm) | Standard Deviation 13.63 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 3 Change | -6.8 beats per minute (bpm) | Standard Deviation 14.26 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 6 Change | -4.3 beats per minute (bpm) | Standard Deviation 12.88 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 7 Change | -3.4 beats per minute (bpm) | Standard Deviation 11.72 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 3 Observed | 68.3 beats per minute (bpm) | Standard Deviation 12.23 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 2 Change | -6.2 beats per minute (bpm) | Standard Deviation 13.75 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 7 Observed | 73.6 beats per minute (bpm) | Standard Deviation 11.74 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 4 Change | -5.0 beats per minute (bpm) | Standard Deviation 15.35 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 2 Change | -9.1 beats per minute (bpm) | Standard Deviation 14.3 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 6 Change | -5.1 beats per minute (bpm) | Standard Deviation 14.79 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 7 Change | -9.5 beats per minute (bpm) | Standard Deviation 13.96 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 4 Observed | 67.8 beats per minute (bpm) | Standard Deviation 13.8 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 7 Observed | 67.4 beats per minute (bpm) | Standard Deviation 13.44 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 2 Observed | 65.9 beats per minute (bpm) | Standard Deviation 12.41 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 5 Observed | 68.3 beats per minute (bpm) | Standard Deviation 12.84 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 4 Change | -6.8 beats per minute (bpm) | Standard Deviation 16.59 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 3 Observed | 65.9 beats per minute (bpm) | Standard Deviation 11.68 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 1 Change | -7.3 beats per minute (bpm) | Standard Deviation 13.59 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 5 Change | -6.0 beats per minute (bpm) | Standard Deviation 15.26 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 3 Change | -9.2 beats per minute (bpm) | Standard Deviation 14.25 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 1 Observed | 67.6 beats per minute (bpm) | Standard Deviation 12.55 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 6 Observed | 68.9 beats per minute (bpm) | Standard Deviation 13.05 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 6 Observed | 71.2 beats per minute (bpm) | Standard Deviation 12.43 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 5 Change | -4.4 beats per minute (bpm) | Standard Deviation 13.53 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 2 Observed | 66.4 beats per minute (bpm) | Standard Deviation 12.55 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 2 Change | -8.6 beats per minute (bpm) | Standard Deviation 14.3 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 1 Observed | 67.7 beats per minute (bpm) | Standard Deviation 12.08 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 7 Change | 24 beats per minute (bpm) | Standard Deviation 13.29 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 4 Change | -4.5 beats per minute (bpm) | Standard Deviation 14.74 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 4 Observed | 69.9 beats per minute (bpm) | Standard Deviation 12.8 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 6 Change | -2.8 beats per minute (bpm) | Standard Deviation 13.55 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 1 Change | -7.0 beats per minute (bpm) | Standard Deviation 12.82 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 3 Observed | 67.4 beats per minute (bpm) | Standard Deviation 12.01 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 5 Observed | 70.0 beats per minute (bpm) | Standard Deviation 11.2 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 3 Change | -7.8 beats per minute (bpm) | Standard Deviation 13.7 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 7 Observed | 69.8 beats per minute (bpm) | Standard Deviation 11.59 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 10 Observed | 80.0 beats per minute (bpm) | Standard Deviation 13.29 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 4 Observed | 70.6 beats per minute (bpm) | Standard Deviation 11.83 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 12 Observed | 79.7 beats per minute (bpm) | Standard Deviation 11.89 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 4 Change | -5.2 beats per minute (bpm) | Standard Deviation 13.76 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 10 Change | 3.2 beats per minute (bpm) | Standard Deviation 14.82 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 5 Observed | 76.3 beats per minute (bpm) | Standard Deviation 13.49 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 5 Change | -0.3 beats per minute (bpm) | Standard Deviation 15.14 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 11 Observed | 79.3 beats per minute (bpm) | Standard Deviation 13.93 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 6 Observed | 75.2 beats per minute (bpm) | Standard Deviation 12.24 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 14 Change | 2.4 beats per minute (bpm) | Standard Deviation 14.27 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 14 Observed | 76.4 beats per minute (bpm) | Standard Deviation 11.66 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 6 Change | -1.6 beats per minute (bpm) | Standard Deviation 14.82 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 13 Change | 2.4 beats per minute (bpm) | Standard Deviation 14.79 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 13 Observed | 76.6 beats per minute (bpm) | Standard Deviation 13.2 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 11 Change | 3.2 beats per minute (bpm) | Standard Deviation 13.4 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 7 Observed | 73.6 beats per minute (bpm) | Standard Deviation 11.46 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 12 Change | 4.0 beats per minute (bpm) | Standard Deviation 14.22 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 7 Change | -3.4 beats per minute (bpm) | Standard Deviation 15.07 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 8 Observed | 77.7 beats per minute (bpm) | Standard Deviation 12.71 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 8 Change | 1.6 beats per minute (bpm) | Standard Deviation 15.25 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 9 Observed | 79.6 beats per minute (bpm) | Standard Deviation 10.77 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 9 Change | 2.8 beats per minute (bpm) | Standard Deviation 11.8 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 6 Change | -1.6 beats per minute (bpm) | Standard Deviation 14.29 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 11 Observed | 74.5 beats per minute (bpm) | Standard Deviation 12.49 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 10 Change | 1.1 beats per minute (bpm) | Standard Deviation 16.97 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 7 Change | -7.7 beats per minute (bpm) | Standard Deviation 10.63 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 5 Observed | 73.3 beats per minute (bpm) | Standard Deviation 11.44 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 8 Observed | 72.6 beats per minute (bpm) | Standard Deviation 13.45 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 4 Change | -3.3 beats per minute (bpm) | Standard Deviation 13.25 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 8 Change | -3.8 beats per minute (bpm) | Standard Deviation 13.48 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 10 Observed | 77.9 beats per minute (bpm) | Standard Deviation 16.42 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 9 Observed | 75.1 beats per minute (bpm) | Standard Deviation 11.19 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 4 Observed | 72.4 beats per minute (bpm) | Standard Deviation 12.46 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 13 Change | 0.8 beats per minute (bpm) | Standard Deviation 11.75 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 9 Change | -1.7 beats per minute (bpm) | Standard Deviation 11.18 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 6 Observed | 74.8 beats per minute (bpm) | Standard Deviation 13.1 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 7 Observed | 67.1 beats per minute (bpm) | Standard Deviation 8.84 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 12 Change | -3.6 beats per minute (bpm) | Standard Deviation 12.29 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 5 Change | -3.2 beats per minute (bpm) | Standard Deviation 13.7 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 12 Observed | 72.3 beats per minute (bpm) | Standard Deviation 11.68 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 11 Change | -1.4 beats per minute (bpm) | Standard Deviation 12.92 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Pulse (Bpm): Vital Signs | Day 13 Observed | 75.5 beats per minute (bpm) | Standard Deviation 13.61 |
Primary
Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign
Baseline vital signs were defined by the assessment value at screening when subjects were not experiencing opioid withdrawal to reduce the potential for variability from the effects of different states of withdrawal that may have been present before dosing on Day 1. Overall screening values are captured in the column Inpatient: Pre 8AM; these values were recorded at various times for each participant during the screening visit, not necessarily at 8AM. Serial vital sign assessments required for inpatient visits on days 1-3, either inpatient or outpatient for days 4-7, and outpatient only for days 8-14. Day 14 only required pre-dose vital signs measurement. Day 1 Change, Pre 8AM was prior to the first dose.
Time frame: Day 1 to Day 14
Population: Participants Analyzed does not match the Participant Flow because some patient data was missing for the visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 2 Observed | 116.8 mmHg | Standard Deviation 15.77 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 7 Change | -4.4 mmHg | Standard Deviation 16.5 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 3 Observed | 116.0 mmHg | Standard Deviation 15.66 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Screening | 121.9 mmHg | Standard Deviation 11.85 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 6 Observed | 115.2 mmHg | Standard Deviation 16.13 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 3 Change | -5.9 mmHg | Standard Deviation 16.38 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 6 Change | -6.5 mmHg | Standard Deviation 15.89 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 2 Change | -5.0 mmHg | Standard Deviation 16.21 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 5 Change | -6.3 mmHg | Standard Deviation 15.86 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 4 Observed | 116.2 mmHg | Standard Deviation 15.32 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 5 Observed | 115.4 mmHg | Standard Deviation 14.76 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 1 Observed | 122.2 mmHg | Standard Deviation 13.89 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 4 Change | -6.0 mmHg | Standard Deviation 15.47 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 7 Observed | 118.0 mmHg | Standard Deviation 16.44 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 6 Observed | 113.4 mmHg | Standard Deviation 14.81 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 4 Observed | 113.7 mmHg | Standard Deviation 14.26 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 7 Change | -5.4 mmHg | Standard Deviation 14.82 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 4 Change | -8.1 mmHg | Standard Deviation 14.65 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 1 Change | -12.2 mmHg | Standard Deviation 15.25 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 1 Observed | 109.7 mmHg | Standard Deviation 15.47 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 7 Observed | 116.4 mmHg | Standard Deviation 14.82 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 2 Observed | 114.8 mmHg | Standard Deviation 15.82 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 6 Change | -8.7 mmHg | Standard Deviation 14.74 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 2 Change | -7.0 mmHg | Standard Deviation 15.65 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 3 Observed | 116.1 mmHg | Standard Deviation 15.75 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 5 Change | -7.1 mmHg | Standard Deviation 16.87 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 3 Change | -5.8 mmHg | Standard Deviation 16.22 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 5 Observed | 114.8 mmHg | Standard Deviation 15.06 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 2 Observed | 114.5 mmHg | Standard Deviation 14.3 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 7 Change | -5.1 mmHg | Standard Deviation 12.87 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 3 Observed | 114.3 mmHg | Standard Deviation 14.71 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 7 Observed | 114.9 mmHg | Standard Deviation 15.45 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 5 Change | -6.6 mmHg | Standard Deviation 15.46 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 5 Observed | 115.2 mmHg | Standard Deviation 13.69 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 1 Change | -10.8 mmHg | Standard Deviation 15.21 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 4 Change | -7.7 mmHg | Standard Deviation 14.77 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 4 Observed | 114.4 mmHg | Standard Deviation 14.85 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 3 Change | -7.5 mmHg | Standard Deviation 16.4 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 1 Observed | 111.1 mmHg | Standard Deviation 16.07 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 6 Observed | 114.0 mmHg | Standard Deviation 14.52 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 2 Change | -7.3 mmHg | Standard Deviation 15.53 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 6 Change | -8.0 mmHg | Standard Deviation 14.88 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 2 Observed | 115.7 mmHg | Standard Deviation 16.2 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 1 Observed | 112.6 mmHg | Standard Deviation 15.91 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 1 Change | -9.4 mmHg | Standard Deviation 16.05 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 2 Change | -6.2 mmHg | Standard Deviation 16.43 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 3 Observed | 116.9 mmHg | Standard Deviation 16.21 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 3 Change | -5.0 mmHg | Standard Deviation 17.3 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 4 Observed | 118.6 mmHg | Standard Deviation 14.77 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 4 Change | -3.7 mmHg | Standard Deviation 15.31 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 5 Observed | 116.3 mmHg | Standard Deviation 15.72 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 5 Change | -5.6 mmHg | Standard Deviation 16.76 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 6 Observed | 116.8 mmHg | Standard Deviation 16.74 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 6 Change | -5.1 mmHg | Standard Deviation 16.57 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 7 Observed | 117.9 mmHg | Standard Deviation 11.32 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 7 Change | -3.0 mmHg | Standard Deviation 13.44 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 5 Observed | 117.1 mmHg | Standard Deviation 14.78 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 3 Observed | 116.9 mmHg | Standard Deviation 15.9 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 1 Observed | 114.1 mmHg | Standard Deviation 15.38 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 5 Change | -4.8 mmHg | Standard Deviation 16.64 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 2 Observed | 117.4 mmHg | Standard Deviation 16.55 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 4 Change | -3.0 mmHg | Standard Deviation 15.24 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 1 Change | -8.0 mmHg | Standard Deviation 15.12 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 6 Change | -5.5 mmHg | Standard Deviation 15.1 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 7 Change | -3.0 mmHg | Standard Deviation 11.43 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 4 Observed | 118.7 mmHg | Standard Deviation 14.68 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 2 Change | -4.5 mmHg | Standard Deviation 17.1 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 7 Observed | 117.9 mmHg | Standard Deviation 12.2 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 6 Observed | 116.6 mmHg | Standard Deviation 15.03 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 3 Change | -5.0 mmHg | Standard Deviation 16.88 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 6 Observed | 117.5 mmHg | Standard Deviation 16.57 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 1 Change | -5.2 mmHg | Standard Deviation 19.16 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 4 Observed | 120.0 mmHg | Standard Deviation 15.24 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 2 Observed | 119.7 mmHg | Standard Deviation 18.01 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 6 Change | -4.5 mmHg | Standard Deviation 17.13 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 5 Observed | 117.2 mmHg | Standard Deviation 14.62 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 4 Change | -1.8 mmHg | Standard Deviation 16.36 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 7 Change | 0.2 mmHg | Standard Deviation 15.23 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 3 Observed | 118.2 mmHg | Standard Deviation 16.64 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 5 Change | -4.8 mmHg | Standard Deviation 15.46 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 1 Observed | 116.9 mmHg | Standard Deviation 17.94 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 7 Observed | 121.1 mmHg | Standard Deviation 14.84 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 3 Change | -3.8 mmHg | Standard Deviation 17.08 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 2 Change | -2.1 mmHg | Standard Deviation 18.03 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 5 Observed | 117.0 mmHg | Standard Deviation 13.48 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 4 Change | -4.0 mmHg | Standard Deviation 16.1 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 3 Change | -4.9 mmHg | Standard Deviation 16.17 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 3 Observed | 117.1 mmHg | Standard Deviation 15.7 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 5 Change | -4.9 mmHg | Standard Deviation 14.93 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 2 Change | -3.9 mmHg | Standard Deviation 17.24 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 6 Observed | 118.4 mmHg | Standard Deviation 16.46 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 2 Observed | 117.9 mmHg | Standard Deviation 16.04 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 6 Change | -3.5 mmHg | Standard Deviation 15.41 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 1 Change | -5.3 mmHg | Standard Deviation 17.69 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 7 Observed | 118.5 mmHg | Standard Deviation 12.08 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 1 Observed | 116.7 mmHg | Standard Deviation 16.82 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 7 Change | -1.7 mmHg | Standard Deviation 16.3 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 4 Observed | 117.7 mmHg | Standard Deviation 13.9 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 14 Change | 7.6 mmHg | Standard Deviation 10.8 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 14 Observed | 128.0 mmHg | Standard Deviation 12.62 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 13 Change | 4.0 mmHg | Standard Deviation 13.62 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 13 Observed | 124.8 mmHg | Standard Deviation 12.48 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 7 Observed | 120.8 mmHg | Standard Deviation 12.99 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 5 Change | -6.3 mmHg | Standard Deviation 16.02 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 6 Observed | 118.7 mmHg | Standard Deviation 15.19 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 5 Observed | 116.7 mmHg | Standard Deviation 12.12 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 7 Change | 2.6 mmHg | Standard Deviation 16.29 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 8 Observed | 118.4 mmHg | Standard Deviation 11.69 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 8 Change | -2.8 mmHg | Standard Deviation 14.03 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 9 Observed | 124.3 mmHg | Standard Deviation 13.14 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 9 Change | 3.6 mmHg | Standard Deviation 14.43 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 10 Observed | 122.2 mmHg | Standard Deviation 14.41 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 10 Change | 1.2 mmHg | Standard Deviation 14.12 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 11 Observed | 121.2 mmHg | Standard Deviation 12.54 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 11 Change | 0.7 mmHg | Standard Deviation 13.52 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 12 Observed | 126.3 mmHg | Standard Deviation 9.75 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 12 Change | 4.3 mmHg | Standard Deviation 9.2 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 4 Observed | 117.0 mmHg | Standard Deviation 12.44 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 6 Change | -3.6 mmHg | Standard Deviation 18.44 |
| Outpatient: Predose | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 4 Change | -4.7 mmHg | Standard Deviation 14.54 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 4 Observed | 115.7 mmHg | Standard Deviation 8.6 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 5 Change | -4.7 mmHg | Standard Deviation 14.97 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 9 Change | 1.4 mmHg | Standard Deviation 14.75 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 12 Observed | 120.4 mmHg | Standard Deviation 12.22 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 7 Observed | 116.3 mmHg | Standard Deviation 9.96 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 4 Change | -5.5 mmHg | Standard Deviation 11.15 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 10 Observed | 124.3 mmHg | Standard Deviation 17.24 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 13 Observed | 123.5 mmHg | Standard Deviation 10.61 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 6 Observed | 122.0 mmHg | Standard Deviation 15.14 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 5 Observed | 118.3 mmHg | Standard Deviation 11.06 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 10 Change | 3.6 mmHg | Standard Deviation 17.67 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 12 Change | -1.4 mmHg | Standard Deviation 12.1 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 6 Change | 0.4 mmHg | Standard Deviation 19.39 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 7 Change | -5.1 mmHg | Standard Deviation 12.91 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 11 Observed | 125.1 mmHg | Standard Deviation 14.16 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 8 Observed | 122.8 mmHg | Standard Deviation 13.15 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 13 Change | 3.0 mmHg | Standard Deviation 14.38 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 8 Change | 2.1 mmHg | Standard Deviation 13.41 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 11 Change | 4.6 mmHg | Standard Deviation 15.39 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Seated Systolic Blood Pressure (mmHg): Vital Sign | Day 9 Observed | 122.3 mmHg | Standard Deviation 16.51 |
Primary
Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign
Baseline vital signs were defined by the assessment value at screening when subjects were not experiencing opioid withdrawal to reduce the potential for variability from the effects of different states of withdrawal that may have been present before dosing on Day 1. Overall screening values are captured in the column Inpatient: Pre 8AM; these values were recorded at various times for each participant during the screening visit, not necessarily at 8AM. Serial vital sign assessments required for inpatient visits on days 1-3, either inpatient or outpatient for days 4-7, and outpatient only for days 8-14. Day 14 only required pre-dose vital signs measurement. Day 1 Change, Pre 8AM was prior to the first dose.
Time frame: Day 1 to Day 14
Population: Participant Number Analyzed does not match the Participant Flow because some patient data was not captured for the visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 2 Observed | 73.4 mmHg | Standard Deviation 11.02 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 7 Observed | 73.6 mmHg | Standard Deviation 11.16 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 3 Observed | 74.0 mmHg | Standard Deviation 12.03 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 2 Change | -6.5 mmHg | Standard Deviation 11.83 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 6 Change | -7.1 mmHg | Standard Deviation 11.4 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 6 Observed | 72.9 mmHg | Standard Deviation 10.11 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 1 Observed | 79.8 mmHg | Standard Deviation 8.65 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 7 Change | -6.2 mmHg | Standard Deviation 12.37 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 5 Change | -7.6 mmHg | Standard Deviation 11.99 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 5 Observed | 72.4 mmHg | Standard Deviation 10.04 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 4 Change | -7.0 mmHg | Standard Deviation 12.08 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 4 Observed | 73.2 mmHg | Standard Deviation 11.8 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 3 Change | -6.2 mmHg | Standard Deviation 12.37 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 5 Change | -10.0 mmHg | Standard Deviation 11.47 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 1 Observed | 68.8 mmHg | Standard Deviation 11.34 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 1 Change | -11.1 mmHg | Standard Deviation 11.58 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 2 Observed | 70.7 mmHg | Standard Deviation 11.2 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 2 Change | -9.4 mmHg | Standard Deviation 12.26 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 3 Observed | 70.6 mmHg | Standard Deviation 11.9 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 3 Change | -9.4 mmHg | Standard Deviation 13.09 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 4 Observed | 70.6 mmHg | Standard Deviation 11.11 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 4 Change | -9.4 mmHg | Standard Deviation 11.9 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 5 Observed | 70.0 mmHg | Standard Deviation 10.46 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 6 Observed | 69.3 mmHg | Standard Deviation 10.11 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 6 Change | -10.7 mmHg | Standard Deviation 12.2 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 7 Observed | 73.2 mmHg | Standard Deviation 11.07 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 7 Change | -7.4 mmHg | Standard Deviation 11.17 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 3 Change | -10.0 mmHg | Standard Deviation 11.74 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 6 Observed | 71.1 mmHg | Standard Deviation 10.7 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 4 Observed | 71.2 mmHg | Standard Deviation 11.12 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 7 Change | -9.5 mmHg | Standard Deviation 9.83 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 5 Observed | 70.7 mmHg | Standard Deviation 10.76 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 2 Observed | 71.0 mmHg | Standard Deviation 11.48 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 4 Change | -9.2 mmHg | Standard Deviation 11.96 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 2 Change | -9.1 mmHg | Standard Deviation 12.74 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 5 Change | -9.2 mmHg | Standard Deviation 12.07 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 1 Observed | 70.3 mmHg | Standard Deviation 11.03 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 7 Observed | 70.3 mmHg | Standard Deviation 11.17 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 3 Observed | 70.0 mmHg | Standard Deviation 10.53 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 1 Change | -9.5 mmHg | Standard Deviation 11.26 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 6 Change | -8.9 mmHg | Standard Deviation 11.6 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 5 Observed | 70.3 mmHg | Standard Deviation 10.99 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 7 Observed | 71.3 mmHg | Standard Deviation 11.69 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 6 Change | -9.8 mmHg | Standard Deviation 12.77 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 3 Change | -10.1 mmHg | Standard Deviation 11.91 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 1 Observed | 69.8 mmHg | Standard Deviation 11.87 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 3 Observed | 70.0 mmHg | Standard Deviation 10.62 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 2 Change | -8.5 mmHg | Standard Deviation 12.48 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 4 Observed | 71.5 mmHg | Standard Deviation 10.98 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 2 Observed | 71.6 mmHg | Standard Deviation 11.85 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 4 Change | -8.9 mmHg | Standard Deviation 12.91 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 1 Change | -10.0 mmHg | Standard Deviation 12.57 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 7 Change | -9.7 mmHg | Standard Deviation 12.29 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 5 Change | -9.6 mmHg | Standard Deviation 13 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 6 Observed | 70.2 mmHg | Standard Deviation 11.15 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 4 Change | -8.0 mmHg | Standard Deviation 11.71 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 2 Observed | 72.2 mmHg | Standard Deviation 11.78 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 7 Observed | 70.4 mmHg | Standard Deviation 11.25 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 4 Observed | 72.2 mmHg | Standard Deviation 10.59 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 5 Observed | 71.1 mmHg | Standard Deviation 11.38 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 7 Change | -10.8 mmHg | Standard Deviation 11.06 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 3 Change | -9.3 mmHg | Standard Deviation 12 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 6 Observed | 71.4 mmHg | Standard Deviation 11.43 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 5 Change | -8.7 mmHg | Standard Deviation 12.76 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 2 Change | -7.9 mmHg | Standard Deviation 13 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 6 Change | -8.6 mmHg | Standard Deviation 12.26 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 1 Observed | 70.7 mmHg | Standard Deviation 11.25 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 1 Change | -9.4 mmHg | Standard Deviation 11.73 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 3 Observed | 70.8 mmHg | Standard Deviation 10.77 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 2 Observed | 72.3 mmHg | Standard Deviation 12.27 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 3 Observed | 71.3 mmHg | Standard Deviation 10.69 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 6 Change | -7.9 mmHg | Standard Deviation 13.33 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 4 Observed | 71.2 mmHg | Standard Deviation 11.09 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 4 Change | -9.0 mmHg | Standard Deviation 12.64 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 7 Change | -8.5 mmHg | Standard Deviation 12.94 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 1 Observed | 71.0 mmHg | Standard Deviation 11.12 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 1 Change | -8.9 mmHg | Standard Deviation 12.71 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 5 Change | -9.8 mmHg | Standard Deviation 12.01 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 5 Observed | 70.2 mmHg | Standard Deviation 11.2 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 2 Change | -7.9 mmHg | Standard Deviation 13.44 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 7 Observed | 72.5 mmHg | Standard Deviation 10.89 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 6 Observed | 72.1 mmHg | Standard Deviation 12.37 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 3 Change | -8.8 mmHg | Standard Deviation 11.91 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 7 Change | -11.8 mmHg | Standard Deviation 11.89 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 3 Observed | 71.5 mmHg | Standard Deviation 10.9 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 1 Change | -9.6 mmHg | Standard Deviation 12.92 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 3 Change | -8.7 mmHg | Standard Deviation 11.78 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 4 Observed | 71.8 mmHg | Standard Deviation 10.14 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 4 Change | -8.2 mmHg | Standard Deviation 11.46 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 5 Observed | 71.1 mmHg | Standard Deviation 10.94 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 1 Observed | 70.4 mmHg | Standard Deviation 11.68 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 5 Change | -9.0 mmHg | Standard Deviation 11.39 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 6 Observed | 72.5 mmHg | Standard Deviation 11.07 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 6 Change | -7.5 mmHg | Standard Deviation 11.88 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 7 Observed | 69.0 mmHg | Standard Deviation 8.93 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 2 Observed | 71.8 mmHg | Standard Deviation 11.52 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 2 Change | -8.4 mmHg | Standard Deviation 13.05 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 14 Observed | 84.8 mmHg | Standard Deviation 8.53 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 13 Change | 4.5 mmHg | Standard Deviation 10.29 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 12 Change | 0.3 mmHg | Standard Deviation 8.62 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 7 Observed | 77.1 mmHg | Standard Deviation 11.43 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 14 Change | 5.5 mmHg | Standard Deviation 9.72 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 5 Change | -5.5 mmHg | Standard Deviation 10.7 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 5 Observed | 74.8 mmHg | Standard Deviation 9.79 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 7 Change | -3.3 mmHg | Standard Deviation 12.24 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 8 Observed | 74.6 mmHg | Standard Deviation 9.22 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 8 Change | -5.8 mmHg | Standard Deviation 10.46 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 9 Observed | 78.4 mmHg | Standard Deviation 9.63 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 9 Change | -1.8 mmHg | Standard Deviation 10.89 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 10 Observed | 76.9 mmHg | Standard Deviation 10.41 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 10 Change | -3.2 mmHg | Standard Deviation 10.32 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 11 Observed | 78.1 mmHg | Standard Deviation 11.01 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 11 Change | -1.7 mmHg | Standard Deviation 10.96 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 4 Change | -4.5 mmHg | Standard Deviation 13.21 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 13 Observed | 83.6 mmHg | Standard Deviation 8.38 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 12 Observed | 80.0 mmHg | Standard Deviation 8.12 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 4 Observed | 75.7 mmHg | Standard Deviation 10.45 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 6 Change | -6.1 mmHg | Standard Deviation 13.61 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 6 Observed | 74.1 mmHg | Standard Deviation 12.33 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 6 Observed | 73.2 mmHg | Standard Deviation 11.31 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 9 Observed | 76.5 mmHg | Standard Deviation 14.02 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 13 Change | 1.1 mmHg | Standard Deviation 12.01 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 9 Change | -4.2 mmHg | Standard Deviation 13.95 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 12 Change | -1.6 mmHg | Standard Deviation 11.95 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 7 Observed | 70.8 mmHg | Standard Deviation 11.27 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 5 Change | -6.3 mmHg | Standard Deviation 12.07 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 10 Observed | 75.9 mmHg | Standard Deviation 11.86 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 12 Observed | 78.7 mmHg | Standard Deviation 9.55 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 5 Observed | 74.5 mmHg | Standard Deviation 10.44 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 10 Change | -4.5 mmHg | Standard Deviation 12.68 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 13 Observed | 80.8 mmHg | Standard Deviation 8.69 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 4 Change | -10.0 mmHg | Standard Deviation 11.81 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 4 Observed | 70.1 mmHg | Standard Deviation 10.26 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 7 Change | -10.4 mmHg | Standard Deviation 15.57 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 11 Observed | 76.0 mmHg | Standard Deviation 9.55 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 8 Observed | 74.5 mmHg | Standard Deviation 13.6 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 6 Change | -6.8 mmHg | Standard Deviation 14.08 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 8 Change | -6.2 mmHg | Standard Deviation 14.23 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Diastolic Blood Pressure (mmHg): Vital Sign | Day 11 Change | -3.9 mmHg | Standard Deviation 9.81 |
Primary
Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs
Baseline vital signs were defined by the assessment value at screening when subjects were not experiencing opioid withdrawal to reduce the potential for variability from the effects of different states of withdrawal that may have been present before dosing on Day 1. Overall screening values are captured in the column Inpatient: Pre 8AM; these values were recorded at various times for each participant during the screening visit, not necessarily at 8AM. Serial vital sign assessments required for inpatient visits on days 1-3, either inpatient or outpatient for days 4-7, and outpatient only for days 8-14. Day 14 only required pre-dose vital signs measurement. Day 1 Change, Pre 8AM was prior to the first dose.
Time frame: Day 1 to Day 14
Population: Participant Number Analyzed does not match the Participant Flow because some patient data was not captured for the visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 2 Observed | 82.4 beats per minute (bpm) | Standard Deviation 15.13 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 5 Observed | 83.1 beats per minute (bpm) | Standard Deviation 16.31 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 6 Observed | 81.7 beats per minute (bpm) | Standard Deviation 14.96 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 1 Observed | 82.8 beats per minute (bpm) | Standard Deviation 13.74 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 2 Change | 1.0 beats per minute (bpm) | Standard Deviation 16.81 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 4 Change | -0.2 beats per minute (bpm) | Standard Deviation 16.09 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 6 Change | 1.4 beats per minute (bpm) | Standard Deviation 16.05 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 1 Change | NA beats per minute (bpm) | — |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 7 Change | 3.5 beats per minute (bpm) | Standard Deviation 18.07 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 3 Change | -0.2 beats per minute (bpm) | Standard Deviation 16.77 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 5 Change | 2.4 beats per minute (bpm) | Standard Deviation 18.58 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 3 Observed | 81.1 beats per minute (bpm) | Standard Deviation 14.82 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 4 Observed | 81.2 beats per minute (bpm) | Standard Deviation 14.93 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 7 Observed | 84.5 beats per minute (bpm) | Standard Deviation 15.44 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 3 Change | -2.6 beats per minute (bpm) | Standard Deviation 16.59 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 4 Observed | 80.1 beats per minute (bpm) | Standard Deviation 14.67 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 4 Change | -1.3 beats per minute (bpm) | Standard Deviation 16.36 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 1 Change | -1.8 beats per minute (bpm) | Standard Deviation 15.18 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 7 Observed | 80.3 beats per minute (bpm) | Standard Deviation 12.44 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 2 Observed | 80.6 beats per minute (bpm) | Standard Deviation 15.19 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 6 Change | -0.5 beats per minute (bpm) | Standard Deviation 16.33 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 2 Change | -0.5 beats per minute (bpm) | Standard Deviation 17.61 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 1 Observed | 79.6 beats per minute (bpm) | Standard Deviation 14.29 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 6 Observed | 79.9 beats per minute (bpm) | Standard Deviation 14.89 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 3 Observed | 79.0 beats per minute (bpm) | Standard Deviation 14.24 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 5 Change | 0.3 beats per minute (bpm) | Standard Deviation 15.33 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 7 Change | 0.2 beats per minute (bpm) | Standard Deviation 14.16 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 5 Observed | 81.0 beats per minute (bpm) | Standard Deviation 14.06 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 7 Observed | 83.4 beats per minute (bpm) | Standard Deviation 13.89 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 4 Observed | 81.5 beats per minute (bpm) | Standard Deviation 15.4 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 3 Observed | 80.0 beats per minute (bpm) | Standard Deviation 14.67 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 7 Change | -0.5 beats per minute (bpm) | Standard Deviation 16.23 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 5 Change | 1.6 beats per minute (bpm) | Standard Deviation 16.77 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 5 Observed | 82.3 beats per minute (bpm) | Standard Deviation 15.43 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 1 Observed | 80.1 beats per minute (bpm) | Standard Deviation 13.72 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 6 Change | 1.4 beats per minute (bpm) | Standard Deviation 15.99 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 1 Change | -1.3 beats per minute (bpm) | Standard Deviation 14.38 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 2 Change | 0.0 beats per minute (bpm) | Standard Deviation 16.22 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 4 Change | 0.0 beats per minute (bpm) | Standard Deviation 16.85 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 6 Observed | 81.8 beats per minute (bpm) | Standard Deviation 14.9 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 3 Change | -1.5 beats per minute (bpm) | Standard Deviation 15.95 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 2 Observed | 81.1 beats per minute (bpm) | Standard Deviation 13.74 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 2 Observed | 80.5 beats per minute (bpm) | Standard Deviation 14.44 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 1 Observed | 81.3 beats per minute (bpm) | Standard Deviation 14.42 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 1 Change | 0.0 beats per minute (bpm) | Standard Deviation 16.41 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 2 Change | -0.6 beats per minute (bpm) | Standard Deviation 15.44 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 3 Observed | 78.1 beats per minute (bpm) | Standard Deviation 15.09 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 3 Change | -3.3 beats per minute (bpm) | Standard Deviation 17.08 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 4 Observed | 79.9 beats per minute (bpm) | Standard Deviation 15.42 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 4 Change | -1.5 beats per minute (bpm) | Standard Deviation 17.75 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 5 Observed | 84.7 beats per minute (bpm) | Standard Deviation 51.39 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 5 Change | 4.2 beats per minute (bpm) | Standard Deviation 50.96 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 6 Observed | 79.5 beats per minute (bpm) | Standard Deviation 14 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 6 Change | -0.9 beats per minute (bpm) | Standard Deviation 16.16 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 7 Observed | 79.0 beats per minute (bpm) | Standard Deviation 13.45 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 7 Change | -4.9 beats per minute (bpm) | Standard Deviation 14.53 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 5 Observed | 80.2 beats per minute (bpm) | Standard Deviation 14.86 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 3 Observed | 79.1 beats per minute (bpm) | Standard Deviation 15.36 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 1 Observed | 81.2 beats per minute (bpm) | Standard Deviation 14.17 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 5 Change | -0.4 beats per minute (bpm) | Standard Deviation 14.8 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 2 Observed | 80.8 beats per minute (bpm) | Standard Deviation 14.46 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 4 Change | -0.7 beats per minute (bpm) | Standard Deviation 18.62 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 1 Change | -0.1 beats per minute (bpm) | Standard Deviation 15.89 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 6 Change | 1.0 beats per minute (bpm) | Standard Deviation 15.28 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 7 Change | -3.6 beats per minute (bpm) | Standard Deviation 16.19 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 4 Observed | 80.8 beats per minute (bpm) | Standard Deviation 16.34 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 2 Change | -0.4 beats per minute (bpm) | Standard Deviation 16 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 7 Observed | 80.0 beats per minute (bpm) | Standard Deviation 14.4 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 6 Observed | 81.5 beats per minute (bpm) | Standard Deviation 13.93 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 3 Change | -2.3 beats per minute (bpm) | Standard Deviation 16.27 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 6 Observed | 80.9 beats per minute (bpm) | Standard Deviation 14.54 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 1 Change | -2.5 beats per minute (bpm) | Standard Deviation 16.25 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 4 Observed | 78.2 beats per minute (bpm) | Standard Deviation 15.52 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 2 Observed | 78.0 beats per minute (bpm) | Standard Deviation 14.67 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 6 Change | 0.4 beats per minute (bpm) | Standard Deviation 15.68 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 5 Observed | 79.5 beats per minute (bpm) | Standard Deviation 14.08 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 4 Change | -2.7 beats per minute (bpm) | Standard Deviation 17.29 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 7 Change | -8.6 beats per minute (bpm) | Standard Deviation 17.8 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 3 Observed | 76.4 beats per minute (bpm) | Standard Deviation 13.75 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 5 Change | -1.2 beats per minute (bpm) | Standard Deviation 15.68 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 1 Observed | 78.9 beats per minute (bpm) | Standard Deviation 14.14 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 7 Observed | 75.1 beats per minute (bpm) | Standard Deviation 13.69 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 3 Change | -5.0 beats per minute (bpm) | Standard Deviation 16.31 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 2 Change | -3.3 beats per minute (bpm) | Standard Deviation 16.49 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 5 Observed | 80.6 beats per minute (bpm) | Standard Deviation 14.74 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 4 Change | -0.2 beats per minute (bpm) | Standard Deviation 17.49 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 3 Change | -3.2 beats per minute (bpm) | Standard Deviation 16.32 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 3 Observed | 78.3 beats per minute (bpm) | Standard Deviation 13.92 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 5 Change | -0.1 beats per minute (bpm) | Standard Deviation 16.33 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 2 Change | -3.0 beats per minute (bpm) | Standard Deviation 16.62 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 6 Observed | 80.9 beats per minute (bpm) | Standard Deviation 15.77 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 2 Observed | 78.4 beats per minute (bpm) | Standard Deviation 13.95 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 6 Change | 0.4 beats per minute (bpm) | Standard Deviation 16.97 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 1 Change | -1.8 beats per minute (bpm) | Standard Deviation 16 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 7 Observed | 74.3 beats per minute (bpm) | Standard Deviation 12.41 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 1 Observed | 79.4 beats per minute (bpm) | Standard Deviation 14.03 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 7 Change | -9.7 beats per minute (bpm) | Standard Deviation 16.75 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 4 Observed | 80.4 beats per minute (bpm) | Standard Deviation 16.16 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 14 Change | 7.2 beats per minute (bpm) | Standard Deviation 19.63 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 14 Observed | 87.0 beats per minute (bpm) | Standard Deviation 17.66 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 13 Change | 6.2 beats per minute (bpm) | Standard Deviation 17.17 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 13 Observed | 86.6 beats per minute (bpm) | Standard Deviation 13.51 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 7 Observed | 83.2 beats per minute (bpm) | Standard Deviation 13.11 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 5 Change | 2.8 beats per minute (bpm) | Standard Deviation 16.75 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 6 Observed | 86.4 beats per minute (bpm) | Standard Deviation 15.08 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 5 Observed | 85.2 beats per minute (bpm) | Standard Deviation 15.23 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 7 Change | -0.5 beats per minute (bpm) | Standard Deviation 16.99 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 8 Observed | 85.3 beats per minute (bpm) | Standard Deviation 15.03 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 8 Change | 2.5 beats per minute (bpm) | Standard Deviation 18.08 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 9 Observed | 90.7 beats per minute (bpm) | Standard Deviation 16.51 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 9 Change | 6.8 beats per minute (bpm) | Standard Deviation 15.74 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 10 Observed | 88.7 beats per minute (bpm) | Standard Deviation 15.73 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 10 Change | 5.1 beats per minute (bpm) | Standard Deviation 17.47 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 11 Observed | 89.3 beats per minute (bpm) | Standard Deviation 16.55 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 11 Change | 6.4 beats per minute (bpm) | Standard Deviation 16.75 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 12 Observed | 90.8 beats per minute (bpm) | Standard Deviation 16.25 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | 0Day 12 Change | 9.2 beats per minute (bpm) | Standard Deviation 17.91 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 4 Observed | 82.0 beats per minute (bpm) | Standard Deviation 11.75 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 6 Change | 2.6 beats per minute (bpm) | Standard Deviation 16.42 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 4 Change | 0.9 beats per minute (bpm) | Standard Deviation 15.06 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 4 Observed | 83.3 beats per minute (bpm) | Standard Deviation 15.43 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 5 Change | -1.7 beats per minute (bpm) | Standard Deviation 15.9 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 9 Change | -1.1 beats per minute (bpm) | Standard Deviation 14.94 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 12 Observed | 80.0 beats per minute (bpm) | Standard Deviation 13.91 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 7 Observed | 76.9 beats per minute (bpm) | Standard Deviation 11.29 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 4 Change | 2.1 beats per minute (bpm) | Standard Deviation 18.73 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 10 Observed | 85.1 beats per minute (bpm) | Standard Deviation 17.87 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 13 Observed | 81.4 beats per minute (bpm) | Standard Deviation 13.21 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 6 Observed | 84.8 beats per minute (bpm) | Standard Deviation 14.77 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 5 Observed | 80.8 beats per minute (bpm) | Standard Deviation 14.81 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 10 Change | 1.6 beats per minute (bpm) | Standard Deviation 18.66 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | 0Day 12 Change | -1.4 beats per minute (bpm) | Standard Deviation 16.75 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 6 Change | 1.6 beats per minute (bpm) | Standard Deviation 15.33 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 7 Change | -4.3 beats per minute (bpm) | Standard Deviation 12.54 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 11 Observed | 82.0 beats per minute (bpm) | Standard Deviation 16.84 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 8 Observed | 80.7 beats per minute (bpm) | Standard Deviation 14.61 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 13 Change | 1.1 beats per minute (bpm) | Standard Deviation 15.14 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 8 Change | -2.9 beats per minute (bpm) | Standard Deviation 15.07 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 11 Change | -0.1 beats per minute (bpm) | Standard Deviation 17.81 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Pulse (Bpm): Vital Signs | Day 9 Observed | 82.8 beats per minute (bpm) | Standard Deviation 15.66 |
Primary
Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign
Baseline vital signs were defined by the assessment value at screening when subjects were not experiencing opioid withdrawal to reduce the potential for variability from the effects of different states of withdrawal that may have been present before dosing on Day 1. Overall screening values are captured in the column Inpatient: Pre 8AM; these values were recorded at various times for each participant during the screening visit, not necessarily at 8AM. Serial vital sign assessments required for inpatient visits on days 1-3, either inpatient or outpatient for days 4-7, and outpatient only for days 8-14. Day 14 only required pre-dose vital signs measurement. Day 1 Change, Pre 8AM was prior to the first dose.
Time frame: Day 1 to Day 14
Population: Participant Number Analyzed does not match the Participant Flow because some patient data was not captured for the visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 2 Observed | 112.4 mmHg | Standard Deviation 15.85 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 7 Observed | 113.9 mmHg | Standard Deviation 17.1 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 3 Observed | 111.2 mmHg | Standard Deviation 16.61 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 2 Change | -10.0 mmHg | Standard Deviation 16.32 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 6 Change | -10.4 mmHg | Standard Deviation 16.12 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 6 Observed | 112.2 mmHg | Standard Deviation 16.44 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 1 Observed | 120.4 mmHg | Standard Deviation 13.94 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 7 Change | -8.7 mmHg | Standard Deviation 17.74 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 5 Change | -11.1 mmHg | Standard Deviation 15.19 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 5 Observed | 111.3 mmHg | Standard Deviation 15.97 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 4 Change | -10.3 mmHg | Standard Deviation 15.29 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 4 Observed | 112.4 mmHg | Standard Deviation 15.93 |
| OL: Lofexidine HCl | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 3 Change | -11.4 mmHg | Standard Deviation 16.25 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 5 Change | -13.6 mmHg | Standard Deviation 15.83 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 1 Observed | 105.7 mmHg | Standard Deviation 16.7 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 1 Change | -16.8 mmHg | Standard Deviation 16.8 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 2 Observed | 108.5 mmHg | Standard Deviation 15.94 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 2 Change | -14.0 mmHg | Standard Deviation 17.24 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 3 Observed | 108.1 mmHg | Standard Deviation 17.15 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 3 Change | -14.4 mmHg | Standard Deviation 17.22 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 4 Observed | 107.9 mmHg | Standard Deviation 16.18 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 4 Change | -14.4 mmHg | Standard Deviation 15.07 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 5 Observed | 108.9 mmHg | Standard Deviation 15.41 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 6 Observed | 108.8 mmHg | Standard Deviation 15.61 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 6 Change | -14.0 mmHg | Standard Deviation 17.01 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 7 Observed | 113.9 mmHg | Standard Deviation 14.96 |
| Inpatient: 3.5 hr Post 8AM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 7 Change | -8.2 mmHg | Standard Deviation 16.4 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 3 Change | -13.5 mmHg | Standard Deviation 15.73 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 6 Observed | 110.2 mmHg | Standard Deviation 15.25 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 4 Observed | 110.9 mmHg | Standard Deviation 17.93 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 7 Change | -8.8 mmHg | Standard Deviation 16.55 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 5 Observed | 109.2 mmHg | Standard Deviation 14.75 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 2 Observed | 108.0 mmHg | Standard Deviation 15.06 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 4 Change | -11.9 mmHg | Standard Deviation 16.69 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 2 Change | -14.7 mmHg | Standard Deviation 16.29 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 5 Change | -13.2 mmHg | Standard Deviation 16.1 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 1 Observed | 107.9 mmHg | Standard Deviation 16.43 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 7 Observed | 110.1 mmHg | Standard Deviation 17.41 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 3 Observed | 109.1 mmHg | Standard Deviation 15.4 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 1 Change | -14.3 mmHg | Standard Deviation 15.95 |
| Inpatient: Pre 1PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 6 Change | -12.6 mmHg | Standard Deviation 15.3 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 5 Observed | 109.5 mmHg | Standard Deviation 15.75 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 7 Observed | 110.1 mmHg | Standard Deviation 15.32 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 6 Change | -13.8 mmHg | Standard Deviation 17.45 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 3 Change | -14.8 mmHg | Standard Deviation 17.63 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 1 Observed | 106.7 mmHg | Standard Deviation 15.66 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 3 Observed | 107.8 mmHg | Standard Deviation 15.97 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 2 Change | -14.1 mmHg | Standard Deviation 17.11 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 4 Observed | 109.7 mmHg | Standard Deviation 14.74 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 2 Observed | 108.6 mmHg | Standard Deviation 16.9 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 4 Change | -13.2 mmHg | Standard Deviation 15.66 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 1 Change | -15.8 mmHg | Standard Deviation 16.48 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 7 Change | -9.6 mmHg | Standard Deviation 17.71 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 5 Change | -13.0 mmHg | Standard Deviation 17.91 |
| Inpatient: 3.5 hr Post 1PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 6 Observed | 109.1 mmHg | Standard Deviation 16.83 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 4 Change | -9.9 mmHg | Standard Deviation 15.25 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 2 Observed | 109.8 mmHg | Standard Deviation 16.22 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 7 Observed | 112.7 mmHg | Standard Deviation 13.26 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 4 Observed | 112.4 mmHg | Standard Deviation 15.12 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 5 Observed | 110.8 mmHg | Standard Deviation 14.72 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 7 Change | -6.8 mmHg | Standard Deviation 14.1 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 3 Change | -12.6 mmHg | Standard Deviation 17.16 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 6 Observed | 110.7 mmHg | Standard Deviation 16.44 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 5 Change | -11.7 mmHg | Standard Deviation 16.44 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 2 Change | -13.0 mmHg | Standard Deviation 17.07 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 6 Change | -12.3 mmHg | Standard Deviation 16.78 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 1 Observed | 108.2 mmHg | Standard Deviation 16.37 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 1 Change | -14.7 mmHg | Standard Deviation 15.8 |
| Inpatient: Pre 6PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 3 Observed | 110.0 mmHg | Standard Deviation 15.99 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 2 Observed | 110.4 mmHg | Standard Deviation 17.7 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 3 Observed | 110.8 mmHg | Standard Deviation 15.77 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 6 Change | -12.0 mmHg | Standard Deviation 17.84 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 4 Observed | 111.7 mmHg | Standard Deviation 15.81 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 4 Change | -10.8 mmHg | Standard Deviation 16.21 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 7 Change | -4.6 mmHg | Standard Deviation 17.96 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 1 Observed | 108.7 mmHg | Standard Deviation 15.75 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 1 Change | -13.9 mmHg | Standard Deviation 17.31 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 5 Change | -12.3 mmHg | Standard Deviation 17.23 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 5 Observed | 110.2 mmHg | Standard Deviation 16.55 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 2 Change | -12.2 mmHg | Standard Deviation 17.69 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 7 Observed | 114.6 mmHg | Standard Deviation 16.42 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 6 Observed | 110.9 mmHg | Standard Deviation 16.91 |
| Inpatient: 3.5 hr Post 6PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 3 Change | -11.9 mmHg | Standard Deviation 16.61 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 7 Change | -7.3 mmHg | Standard Deviation 17.01 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 3 Observed | 110.5 mmHg | Standard Deviation 16.19 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 1 Change | -13.6 mmHg | Standard Deviation 17.74 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 3 Change | -12.2 mmHg | Standard Deviation 16.09 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 4 Observed | 111.1 mmHg | Standard Deviation 14.79 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 4 Change | -11.3 mmHg | Standard Deviation 15.89 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 5 Observed | 111.4 mmHg | Standard Deviation 15.49 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 1 Observed | 109.0 mmHg | Standard Deviation 16.93 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 5 Change | -11.0 mmHg | Standard Deviation 16.42 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 6 Observed | 112.7 mmHg | Standard Deviation 16.24 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 6 Change | -10.0 mmHg | Standard Deviation 16.1 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 7 Observed | 111.6 mmHg | Standard Deviation 14 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 2 Observed | 110.7 mmHg | Standard Deviation 16.07 |
| Inpatient: Pre 11PM | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 2 Change | -11.9 mmHg | Standard Deviation 16.91 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 14 Observed | 128.8 mmHg | Standard Deviation 9.89 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 13 Change | 1.0 mmHg | Standard Deviation 14.58 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 12 Change | 2.0 mmHg | Standard Deviation 12.76 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 7 Observed | 118.0 mmHg | Standard Deviation 13 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 14 Change | 7.8 mmHg | Standard Deviation 9.92 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 5 Change | -8.4 mmHg | Standard Deviation 14.43 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 5 Observed | 114.6 mmHg | Standard Deviation 12.29 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 7 Change | -4.6 mmHg | Standard Deviation 15.53 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 8 Observed | 117.8 mmHg | Standard Deviation 11.13 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 8 Change | -2.8 mmHg | Standard Deviation 13.53 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 9 Observed | 119.4 mmHg | Standard Deviation 10.62 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 9 Change | -0.8 mmHg | Standard Deviation 13.27 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 10 Observed | 122.3 mmHg | Standard Deviation 14.78 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 10 Change | 1.6 mmHg | Standard Deviation 15.46 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 11 Observed | 123.7 mmHg | Standard Deviation 14.91 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 11 Change | 3.0 mmHg | Standard Deviation 16.2 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 4 Change | -6.1 mmHg | Standard Deviation 17.61 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 13 Observed | 122.7 mmHg | Standard Deviation 11.77 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 12 Observed | 124.3 mmHg | Standard Deviation 11.19 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 4 Observed | 116.6 mmHg | Standard Deviation 15.11 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 6 Change | -5.8 mmHg | Standard Deviation 17.68 |
| Outpatient: Predose | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 6 Observed | 116.6 mmHg | Standard Deviation 15.47 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 6 Observed | 116.4 mmHg | Standard Deviation 16.05 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 9 Observed | 119.5 mmHg | Standard Deviation 17.05 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 13 Change | 3.5 mmHg | Standard Deviation 16.41 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 9 Change | -0.9 mmHg | Standard Deviation 21.35 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 12 Change | -4.1 mmHg | Standard Deviation 16.91 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 7 Observed | 116.6 mmHg | Standard Deviation 15.53 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 5 Change | -7.5 mmHg | Standard Deviation 15.02 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 10 Observed | 121.9 mmHg | Standard Deviation 18.78 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 12 Observed | 118.4 mmHg | Standard Deviation 14.06 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 5 Observed | 116.1 mmHg | Standard Deviation 10.69 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 10 Change | 1.6 mmHg | Standard Deviation 22.89 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 13 Observed | 125.1 mmHg | Standard Deviation 12.25 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 4 Change | -8.8 mmHg | Standard Deviation 13.77 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 4 Observed | 113.4 mmHg | Standard Deviation 11.6 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 7 Change | -5.8 mmHg | Standard Deviation 19.56 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 11 Observed | 123.2 mmHg | Standard Deviation 14.43 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 8 Observed | 117.6 mmHg | Standard Deviation 13.94 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 6 Change | -5.8 mmHg | Standard Deviation 18.68 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 8 Change | -2.5 mmHg | Standard Deviation 18.18 |
| Outpatient: 3.5 hr Postdose | Mean Observed and Change From Screening in Standing Systolic Blood Pressure (mmHg): Vital Sign | Day 11 Change | 1.8 mmHg | Standard Deviation 18.9 |
Primary
Occurrence of Adverse Events (AEs) Not Related to Opioid Withdrawal
Time frame: Day 1 to Day 14
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| OL: Lofexidine HCl | Occurrence of Adverse Events (AEs) Not Related to Opioid Withdrawal | Opioid Withdrawal Related Adverse Events | 233 Participants |
| OL: Lofexidine HCl | Occurrence of Adverse Events (AEs) Not Related to Opioid Withdrawal | Non-Opioid Withdrawal Related Adverse Events | 208 Participants |
Primary
Occurrence of Per Protocol Adverse Events of Special Interest (AESI)
Time frame: Day 1 to Day 14
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| OL: Lofexidine HCl | Occurrence of Per Protocol Adverse Events of Special Interest (AESI) | Orthostatic hypotension | 96 Participants |
| OL: Lofexidine HCl | Occurrence of Per Protocol Adverse Events of Special Interest (AESI) | Orthostatic bradycardia | 0 Participants |
| OL: Lofexidine HCl | Occurrence of Per Protocol Adverse Events of Special Interest (AESI) | Syncope | 1 Participants |
Primary
Overall Occurrence of Serious Treatment Emergent Adverse Events (Serious TEAEs)
Time frame: Days 1-14
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| OL: Lofexidine HCl | Overall Occurrence of Serious Treatment Emergent Adverse Events (Serious TEAEs) | 2 Participants |
Primary
Overall Occurrence of Treatment Emergent Adverse Events (TEAEs)
Subjects with at least 1 TEAE occurring on days 1-14.
Time frame: Days 1-14
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| OL: Lofexidine HCl | Overall Occurrence of Treatment Emergent Adverse Events (TEAEs) | 270 Participants |
Primary
Overall Treatment Emergent Adverse Events (TEAEs) by Severity
Time frame: Days 1-14
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| OL: Lofexidine HCl | Overall Treatment Emergent Adverse Events (TEAEs) by Severity | Mild | 104 Participants |
| OL: Lofexidine HCl | Overall Treatment Emergent Adverse Events (TEAEs) by Severity | Moderate | 158 Participants |
| OL: Lofexidine HCl | Overall Treatment Emergent Adverse Events (TEAEs) by Severity | Severe | 8 Participants |
Primary
Safety Electrocardiograms (ECG) Evaluation Shift From Baseline to Post Dose and End of Study
For each 12-lead ECG obtained during the study, the investigator made an overall interpretation of the ECG (normal, abnormal NCS, and abnormal CS). Shifts from normal at baseline to abnormal NCS and abnormal CS at the end of study predose and postdose assessments were summarized.
Time frame: Day 1 and Day 14
Population: Participants Analyzed does not match the Participant Flow as a result of missing data for some participants.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| OL: Lofexidine HCl | Safety Electrocardiograms (ECG) Evaluation Shift From Baseline to Post Dose and End of Study | End of Study Post Dose | Normal | 77 Participants |
| OL: Lofexidine HCl | Safety Electrocardiograms (ECG) Evaluation Shift From Baseline to Post Dose and End of Study | End of Study Pre Dose | Abnormal (CS) | 1 Participants |
| OL: Lofexidine HCl | Safety Electrocardiograms (ECG) Evaluation Shift From Baseline to Post Dose and End of Study | End of Study Post Dose | Abnormal (CS) | 2 Participants |
| OL: Lofexidine HCl | Safety Electrocardiograms (ECG) Evaluation Shift From Baseline to Post Dose and End of Study | End of Study Pre Dose | Normal | 83 Participants |
| OL: Lofexidine HCl | Safety Electrocardiograms (ECG) Evaluation Shift From Baseline to Post Dose and End of Study | Day 1 Post 8am Dose | Abnormal (CS) | 0 Participants |
| OL: Lofexidine HCl | Safety Electrocardiograms (ECG) Evaluation Shift From Baseline to Post Dose and End of Study | Day 1 Post 8am Dose | Abnormal (NCS) | 41 Participants |
| OL: Lofexidine HCl | Safety Electrocardiograms (ECG) Evaluation Shift From Baseline to Post Dose and End of Study | End of Study Post Dose | Abnormal (NCS) | 41 Participants |
| OL: Lofexidine HCl | Safety Electrocardiograms (ECG) Evaluation Shift From Baseline to Post Dose and End of Study | End of Study Pre Dose | Abnormal (NCS) | 19 Participants |
| OL: Lofexidine HCl | Safety Electrocardiograms (ECG) Evaluation Shift From Baseline to Post Dose and End of Study | Day 1 Post 8am Dose | Normal | 139 Participants |
| Inpatient: 3.5 hr Post 8AM | Safety Electrocardiograms (ECG) Evaluation Shift From Baseline to Post Dose and End of Study | End of Study Pre Dose | Abnormal (NCS) | 38 Participants |
| Inpatient: 3.5 hr Post 8AM | Safety Electrocardiograms (ECG) Evaluation Shift From Baseline to Post Dose and End of Study | End of Study Post Dose | Normal | 26 Participants |
| Inpatient: 3.5 hr Post 8AM | Safety Electrocardiograms (ECG) Evaluation Shift From Baseline to Post Dose and End of Study | End of Study Pre Dose | Abnormal (CS) | 0 Participants |
| Inpatient: 3.5 hr Post 8AM | Safety Electrocardiograms (ECG) Evaluation Shift From Baseline to Post Dose and End of Study | Day 1 Post 8am Dose | Abnormal (NCS) | 87 Participants |
| Inpatient: 3.5 hr Post 8AM | Safety Electrocardiograms (ECG) Evaluation Shift From Baseline to Post Dose and End of Study | Day 1 Post 8am Dose | Normal | 16 Participants |
| Inpatient: 3.5 hr Post 8AM | Safety Electrocardiograms (ECG) Evaluation Shift From Baseline to Post Dose and End of Study | Day 1 Post 8am Dose | Abnormal (CS) | 0 Participants |
| Inpatient: 3.5 hr Post 8AM | Safety Electrocardiograms (ECG) Evaluation Shift From Baseline to Post Dose and End of Study | End of Study Post Dose | Abnormal (CS) | 0 Participants |
| Inpatient: 3.5 hr Post 8AM | Safety Electrocardiograms (ECG) Evaluation Shift From Baseline to Post Dose and End of Study | End of Study Post Dose | Abnormal (NCS) | 47 Participants |
| Inpatient: 3.5 hr Post 8AM | Safety Electrocardiograms (ECG) Evaluation Shift From Baseline to Post Dose and End of Study | End of Study Pre Dose | Normal | 20 Participants |
| Inpatient: Pre 1PM | Safety Electrocardiograms (ECG) Evaluation Shift From Baseline to Post Dose and End of Study | End of Study Pre Dose | Abnormal (NCS) | 0 Participants |
| Inpatient: Pre 1PM | Safety Electrocardiograms (ECG) Evaluation Shift From Baseline to Post Dose and End of Study | Day 1 Post 8am Dose | Normal | 0 Participants |
| Inpatient: Pre 1PM | Safety Electrocardiograms (ECG) Evaluation Shift From Baseline to Post Dose and End of Study | Day 1 Post 8am Dose | Abnormal (NCS) | 0 Participants |
| Inpatient: Pre 1PM | Safety Electrocardiograms (ECG) Evaluation Shift From Baseline to Post Dose and End of Study | Day 1 Post 8am Dose | Abnormal (CS) | 0 Participants |
| Inpatient: Pre 1PM | Safety Electrocardiograms (ECG) Evaluation Shift From Baseline to Post Dose and End of Study | End of Study Pre Dose | Normal | 0 Participants |
| Inpatient: Pre 1PM | Safety Electrocardiograms (ECG) Evaluation Shift From Baseline to Post Dose and End of Study | End of Study Pre Dose | Abnormal (CS) | 0 Participants |
| Inpatient: Pre 1PM | Safety Electrocardiograms (ECG) Evaluation Shift From Baseline to Post Dose and End of Study | End of Study Post Dose | Normal | 0 Participants |
| Inpatient: Pre 1PM | Safety Electrocardiograms (ECG) Evaluation Shift From Baseline to Post Dose and End of Study | End of Study Post Dose | Abnormal (NCS) | 0 Participants |
| Inpatient: Pre 1PM | Safety Electrocardiograms (ECG) Evaluation Shift From Baseline to Post Dose and End of Study | End of Study Post Dose | Abnormal (CS) | 0 Participants |
| Inpatient: 3.5 hr Post 1PM | Safety Electrocardiograms (ECG) Evaluation Shift From Baseline to Post Dose and End of Study | End of Study Post Dose | Normal | 103 Participants |
| Inpatient: 3.5 hr Post 1PM | Safety Electrocardiograms (ECG) Evaluation Shift From Baseline to Post Dose and End of Study | End of Study Pre Dose | Normal | 103 Participants |
| Inpatient: 3.5 hr Post 1PM | Safety Electrocardiograms (ECG) Evaluation Shift From Baseline to Post Dose and End of Study | Day 1 Post 8am Dose | Abnormal (CS) | 0 Participants |
| Inpatient: 3.5 hr Post 1PM | Safety Electrocardiograms (ECG) Evaluation Shift From Baseline to Post Dose and End of Study | End of Study Post Dose | Abnormal (CS) | 2 Participants |
| Inpatient: 3.5 hr Post 1PM | Safety Electrocardiograms (ECG) Evaluation Shift From Baseline to Post Dose and End of Study | End of Study Post Dose | Abnormal (NCS) | 88 Participants |
| Inpatient: 3.5 hr Post 1PM | Safety Electrocardiograms (ECG) Evaluation Shift From Baseline to Post Dose and End of Study | Day 1 Post 8am Dose | Abnormal (NCS) | 128 Participants |
| Inpatient: 3.5 hr Post 1PM | Safety Electrocardiograms (ECG) Evaluation Shift From Baseline to Post Dose and End of Study | End of Study Pre Dose | Abnormal (CS) | 1 Participants |
| Inpatient: 3.5 hr Post 1PM | Safety Electrocardiograms (ECG) Evaluation Shift From Baseline to Post Dose and End of Study | End of Study Pre Dose | Abnormal (NCS) | 57 Participants |
| Inpatient: 3.5 hr Post 1PM | Safety Electrocardiograms (ECG) Evaluation Shift From Baseline to Post Dose and End of Study | Day 1 Post 8am Dose | Normal | 155 Participants |