Attention Deficit Hyperactivity Disorder
Conditions
Brief summary
The purpose of this study is to determine whether PF-03654746 is effective in the treatment of Adult Attention Deficit Hyperactivity Disorder (ADHD). This will be a randomized, double-blind, crossover study in which adults with ADHD will receive 3 weeks of treatment with PF-03654746, either a low dose (1 mg), or flexible dose (0.50 mg titrated up to 2 mg), and 3 weeks of placebo. A washout period will separate the 2 treatment periods. Participants will be required to washout of prior ADHD medication before entering the study. Participants will be required to come to the site for 10 visits over approximately a 10-week period.
Interventions
DRUGPF-03654746
Dosage Form: 0.5 mg capsules of PF-03654746 Dosage: 0.5 mg QD for Days 1-7, then 1.0 mg QD Days 8-14, then 2.0 mg QD Days 15-21
DRUGPlacebo capsules
Dosage Form: matching placebo capsules Dosage: Subjects will take two placebo capsules each morning throughout the 3 week double-blind treatment placebo treatment period.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
Subjects with a diagnosis of Attention Deficit Hyperactivity Disorder, based on clinical assessment and interview. Male and female outpatients. Subjects with a diagnosis of Attention Deficit Hyperactivity Disorder, based on clinical assessment and interview. Female subjects must be of non-childbearing potential.
Exclusion criteria
Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular (including hypertension), hepatic, neurologic, or allergic disease. Current or lifetime history of psychosis or bipolar disorder; any current anxiety disorder (with the exception of social or specific phobia), or substance abuse or dependence in the past 6 months. Current episode of Major Depression or episode within the last 6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Total Score at Week 3 | Baseline, Week 3 | AISRS: an 18-item scale administered by the investigator. It included 9 items that evaluated symptoms of inattention and 9 items that evaluated symptoms of impulsivity and hyperactivity. Each item was rated from 0 (none) to 3 (severe). AISRS total score was calculated as sum of all the items on the scale and ranged from 0 to 54. A higher score corresponded to a worse severity of ADHD. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With at Least 30 Percent Decrease From Baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) Total Score | Week 1, 2, 3 | AISRS: an 18-item scale administered by the investigator. It included 9 items that evaluated symptoms of inattention and 9 items that evaluated symptoms of impulsivity and hyperactivity. Each item was rated from 0 (none) to 3 (severe). AISRS total score was calculated as sum of all the items on the scale and ranged from 0 to 54. A higher score corresponded to a worse severity of ADHD. |
| Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Total Score at Week 1 and 2 | Baseline, Week 1, 2 | AISRS: an 18-item scale administered by the investigator. It included 9 items that evaluated symptoms of inattention and 9 items that evaluated symptoms of impulsivity and hyperactivity. Each item was rated from 0 (none) to 3 (severe). AISRS total score was calculated as sum of all the items on the scale and ranged from 0 to 54. A higher score corresponded to a worse severity of ADHD. |
| Percentage of Participants With 1 or 2 Score on Clinical Global Impression-Severity Scale (CGI-S) | Week 1, 2, 3 | CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Participants with a score of 1 (normal - not ill at all) or 2 (borderline mentally ill) are reported. |
| Percentage of Participants With Less Than or Equal to 18 Score on Adult ADHD Investigator Symptom Rating Scale (AISRS) | Week 1, 2, 3 | AISRS: an 18-item scale administered by the investigator. It included 9 items that evaluated symptoms of inattention and 9 items that evaluated symptoms of impulsivity and hyperactivity. Each item was rated from 0 (none) to 3 (severe). AISRS total score was calculated as sum of all the items on the scale and ranged from 0 to 54. A higher score corresponded to a worse severity of ADHD. |
| Percentage of Participants With Sustained Response of at Least 30 Percent Decrease From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score | Day 7, 14, 21 | TASS: a time sensitive 18-item questionnaire completed by the participant that measured the severity of current ADHD symptoms. It included 9 items that evaluate symptoms of inattention sub-scale and 9 items that evaluate symptoms of impulsivity and hyperactivity sub-scale. Each item was rated from 0 (none) to 3 (severe). TASS total score was calculated as sum of all the items on the scale and ranged from 0 to 54. A higher total score corresponds to a worse severity of ADHD. TASS was administered each day from Day 1 to 14 and on Day 21 in each intervention period. Participants with sustained response were those who had at least 30 percent decrease from baseline in TASS total score, which was maintained at all visits up to the time of assessment. Sustained responders at Day 7, 14 and 21 were analyzed. |
| Change From Baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) Subscale Scores at Week 1, 2 and 3 | Baseline, Week 1, 2, 3 | AISRS: an 18-item scale administered by the investigator. It included 9 items that evaluated symptoms of inattention and 9 items that evaluated symptoms of impulsivity and hyperactivity. Each item was rated from 0 (none) to 3 (severe). The AISRS inattention and hyperactive/impulsive total subscale score range from 0 to 27. A higher total subscale score corresponded to a worse severity of ADHD inattention or hyperactivity/impulsivity. |
| Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score on Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 21 | Baseline, Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 21 | TASS: a time sensitive 18-item questionnaire completed by the participant that measured the severity of current ADHD symptoms. It included 9 items that evaluate symptoms of inattention sub-scale and 9 items that evaluate symptoms of impulsivity and hyperactivity sub-scale. Each item was rated from 0 (none) to 3 (severe). TASS total score was calculated as sum of all the items on the scale and ranged from 0 to 54. A higher total score corresponded to a worse severity of ADHD. TASS was administered each day from Day 1 to 14 and on Day 21 in each intervention period. |
| Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at Week 3 | Baseline, Week 3 | The MADRS scale measures the depression level of a participant. It is administered as a semi-structured clinician interview. The total score is derived by adding the scores of the following 10 items: (1) Apparent sadness; (2) Reported sadness; (3) Inner tension; (4) Reduced sleep; (5) Reduced appetite; (6) Concentration difficulties; (7) Lassitude; (8) Inability to feel; (9) Pessimistic thoughts; (10) Suicidal thoughts. Each item is scored using a 6-point scale which ranges from 0 to 6 (a higher score indicates increased severity). The total score range was 0 to 60 where 0 indicates no depression and 60 indicates severely depressed. |
| Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Week 3 | Baseline, Week 3 | HAM-A is a clinician-rated 14 item scale that provides an overall measure of global anxiety, including psychic (mental agitation and psychological distress) and somatic (physical complaints related to anxiety) symptoms. Each item was scored on a scale ranging from 0 (not present) to 4 (very severe) with a total score range of 0 to 56, where higher score indicates greater anxiety. |
| Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Baseline, Week 3 | AIM-A: 66 item questionnaire completed by the participant to assess the impact of ADHD on the participant's quality of life. It is comprised of 4 global quality of life (QoL) items (current quality of life item \[CQoLI\], range:1 to 10; global limitation item \[GLI\]: range:1 to 4, on the right track item \[RTI\], range:1 to 3, more good days \[GD\] than bad days \[BD\], range:1 to 5, higher scores indicate a better QoL for all the 4 QoL items) and 6 multi-item subscales (living with ADHD, general well-being, performance and daily functioning \[PDF\], relationships and communication \[R/C\], Impact of symptoms-bother/concern \[IS-B/C\] scale, and impact of symptoms-interference \[IS-I\] scale). Participants responded to each item of multi-item subscale using a likert scale ranging from 1 (strongly agree) to 5 (strongly disagree). Multi-item subscale scores were calculated as an average of scores for the contributing items and transformed into 0 to 100 score where higher scores indicate a better QoL. |
| Change From Baseline in Adult ADHD Quality of Life Scale (AAQOL) Subscale Score at Week 3 | Baseline, Week 3 | AAQoL is a 29-item questionnaire consisting of 4 subscales: life productivity (11 items), psychological health (\[PH\] 6 items), life outlook (7 items) and relationships (5 items). Participants rated each item on a scale ranging from 1 (not at all/never) to 5 (extremely/very often). The scores of each item were then transformed to a 0 to 100 point scale, higher scores indicating better quality of life. The score for each subscale was calculated as the sum of the corresponding item scores. Total score ranges were: life productivity (0 to 1100), psychological health (0 to 600), life outlook (0 to 700) and relationships (0 to 500), where higher subscale score indicates better quality of life for each subscale. |
| Change From Baseline in Sheehan Disability Scale (SDS) Subscale Scores at Week 3 | Baseline, Week 3 | SDS was a participant-rated questionnaire assessing the effect of the participant's symptoms on the 3 domains/subscales: work/school, social life/leisure activities, and family/home management. Each domain was rated on visual analog scale ranges from 0 to 10 where 0=not at all impaired and 10=extremely impaired, and total SDS score was calculated as a sum of all the domains with a score range of 0=not at all impaired to 30=extremely impaired. Disability scores were reported for each of the domains/subscales. Higher scores reflect greater impairment. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Subjective Sleep Questionnaire (SSQ) Hours of Sleep Subscale Scores at Week 1, 2 and 3 | Baseline, Week 1, 2, 3 | SSQ is a 5-item self-report scale that was designed to evaluate the amount and quality of sleep and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), WASO (1 item), quality of sleep (1 item). Hours of sleep subscale score ranges from 0-16 hours. Higher value indicates better sleep. |
| Change From Baseline in Subjective Sleep Questionnaire (SSQ) Number of Awakenings Subscale Scores at Week 1, 2 and 3 | Baseline, Week 1, 2, 3 | SSQ is a 5-item self-report scale that was designed to evaluate the amount and quality of sleep and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), WASO (1 item), quality of sleep (1 item). Number of awakenings subscale score ranges from 0 to 30. Lower value indicates better sleep. |
| Change From Baseline in Subjective Sleep Questionnaire (SSQ) Total Awake After Sleep Onset (WASO) Subscale Scores at Week 1, 2 and 3 | Baseline, Week 1, 2, 3 | SSQ is a 5-item self-report scale that was designed to evaluate the amount and quality of sleep and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), WASO (1 item), quality of sleep (1 item). Total WASO subscale score ranges from 0 to 24 hours. Lower value indicates better sleep. |
| Change From Baseline in Subjective Sleep Questionnaire (SSQ) Quality of Sleep Subscale Scores at Week 1, 2 and 3 | Baseline, Week 1, 2, 3 | SSQ is a 5-item self-report scale that was designed to evaluate the amount and quality of sleep and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), WASO (1 item), quality of sleep (1 item). Quality of sleep subscale score ranges from 0-100. Higher score indicates better quality of sleep. |
| Number of Participants With Clinically Significant Laboratory Test Abnormalities | Baseline up to 1 week after last study dose | Laboratory parameters included hematology (hemoglobin, hematocrit, red blood cell count, platelets, leukocytes, total neutrophils, eosinophils, basophils, lymphocytes, monocytes); liver function (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, albumin, total protein); renal function (creatinine, blood urea nitrogen, uric acid, sodium, potassium, chloride, bicarbonate, calcium); urinalysis (protein, blood), and clinical chemistry (glucose). |
| Number of Participants With Electrocardiogram (ECG) Findings | Baseline up to End of Treatment (Week 3 of period 2) | Criteria for potential clinical concern in ECG parameters: maximum PR interval of greater than or equal to (\>=) 300 milliseconds (msec), maximum QRS interval \>=200 msec, maximum QTc interval of 450 to \<480 msec, 480 to \<500 msec and \>=500 msec. |
| Number of Participants With Clinically Significant Vital Sign Abnormalities | Baseline up to 1 week after last study dose | Criteria for potential clinical concern in vital signs: systolic blood pressure (BP) less than (\<) 90 millimeters of mercury (mmHg), diastolic BP \<50 mmHg, supine and sitting heart rate \<40 beats per minute (bpm) or \>120 bpm, standing and erect heart rate \<40 bpm or \>140 bpm. Maximum increase from baseline in systolic BP \>=30 mmHg, maximum increase from baseline in diastolic BP \>=20 mmHg. |
| Number of Participants With Change From Baseline in Physical Examination and Neurological Examination | Baseline up to 1 week after last study dose (1 week after end of Period 2) | Analysis include general physical examination and assessment of head, ears, eyes, ocular fundi, nose, mouth, throat, neck, thyroid, lungs, heart, breasts, abdomen and musculoskeletal system. |
| Treatment Duration | Day 1 up to Day 21 | Treatment duration was defined as the total number of dosing days from first to last day of study drug administration in each period. |
| Change From Baseline in Subjective Sleep Questionnaire (SSQ) Latency Subscale Scores at Week 1, 2 and 3 | Baseline, Week 1, 2, 3 | SSQ is a 5-item self-report scale that was designed to evaluate the amount and quality of sleep and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total awake after sleep onset (WASO \[1 item\]), quality of sleep (1 item). Latency subscale score ranges from 0-840 minutes. Lower value indicates better sleep. |
| Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Baseline, Week 1, 2, 3 | Participant-rated 12-item questionnaire to assess sleep quality and quantity. The items contribute to each scale and are averaged to create the 7 subscale scores: sleep disturbance, snoring, awaken short of breath (ASoB) or with a headache, somnolence, sleep adequacy, sleep quantity (range 0 to 24) and optimal sleep, and overall sleep problem index (SPI) I (range 0 to 600) and II. Except for sleep quantity and sleep problem index I, scores are transformed (actual raw score minus lowest possible score divided by possible raw score range\* 100); total score range: 0 to 100; higher score = greater intensity of attribute. Except for sleep quantity, higher scores=greater impairment. Scales with at least one item answered was used to generate a scale score. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo First, Then PF-03654746 (Low Dose) Placebo matched to PF-03654746 capsule orally once daily for 3 weeks in first double-blind (DB) intervention period and then low dose of PF-03654746 capsule 1 milligram (mg) orally once daily for 3 weeks in second DB intervention period. A washout period of at least 7 days was maintained between each treatment period. | 16 |
| PF-03654746 (Low Dose) First, Then Placebo Low dose of PF-03654746 capsule 1 mg orally once daily for 3 weeks in first DB intervention period and then placebo matched to PF-03654746 capsule orally once daily for 3 weeks in second DB intervention period. A washout period of at least 7 days was maintained between each treatment period. | 17 |
| Placebo First, Then PF-03654746 (Flexible Dose) Placebo matched to PF-03654746 capsule orally once daily in the first DB intervention period and then PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator's discretion and tolerability, in the second DB intervention period. A washout period of at least 7 days was maintained between each treatment period. | 16 |
| PF-03654746 (Flexible Dose) First, Then Placebo PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator's discretion and tolerability, in the first DB intervention period and then placebo matched to PF-03654746 capsule orally once daily in the second DB intervention period. A washout period of at least 7 days was maintained between each treatment period. | 16 |
| Total | 65 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| First Double-blind Intervention Period | Adverse Event | 2 | 0 | 1 | 1 |
| First Double-blind Intervention Period | Lost to Follow-up | 0 | 0 | 1 | 1 |
| First Double-blind Intervention Period | Other | 1 | 4 | 4 | 0 |
| First Double-blind Intervention Period | Randomized but not treated | 1 | 0 | 0 | 0 |
| First Double-blind Intervention Period | Withdrawal by Subject | 2 | 0 | 1 | 1 |
| Second Double-blind Intervention Period | Adverse Event | 1 | 1 | 0 | 0 |
| Second Double-blind Intervention Period | Lost to Follow-up | 0 | 0 | 0 | 1 |
| Second Double-blind Intervention Period | Other | 1 | 1 | 0 | 0 |
| Second Double-blind Intervention Period | Withdrawal by Subject | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo First, Then PF-03654746 (Low Dose) | PF-03654746 (Low Dose) First, Then Placebo | Placebo First, Then PF-03654746 (Flexible Dose) | PF-03654746 (Flexible Dose) First, Then Placebo | Total |
|---|---|---|---|---|---|
| Age, Continuous | 37.3 years STANDARD_DEVIATION 12.6 | 38.4 years STANDARD_DEVIATION 10.6 | 37.9 years STANDARD_DEVIATION 10.2 | 35.9 years STANDARD_DEVIATION 9.6 | 37.4 years STANDARD_DEVIATION 10.6 |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 16 Participants | 17 Participants | 16 Participants | 16 Participants | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 21 / 28 | 19 / 25 | 33 / 58 |
| serious Total, serious adverse events | 0 / 28 | 0 / 25 | 0 / 58 |
Outcome results
Primary
Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Total Score at Week 3
AISRS: an 18-item scale administered by the investigator. It included 9 items that evaluated symptoms of inattention and 9 items that evaluated symptoms of impulsivity and hyperactivity. Each item was rated from 0 (none) to 3 (severe). AISRS total score was calculated as sum of all the items on the scale and ranged from 0 to 54. A higher score corresponded to a worse severity of ADHD.
Time frame: Baseline, Week 3
Population: Per Protocol (PP) set: all participants included in full analysis set (FAS=who received at least\[\>=\]1 dose of randomized study drug,had baseline and \>=1 post-baseline measurement of primary efficacy variable)and had no major protocol violation affecting primary efficacy variable. n=participants evaluable at specified time points for each arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-03654746 (Low Dose) | Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Total Score at Week 3 | Baseline (n=27, 22, 52) | 36.778 units on a scale | Standard Deviation 8.5545 |
| PF-03654746 (Low Dose) | Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Total Score at Week 3 | Change at Week 3 (n=25, 21, 48) | -7.196 units on a scale | Standard Deviation 8.7318 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Total Score at Week 3 | Change at Week 3 (n=25, 21, 48) | -5.745 units on a scale | Standard Deviation 9.9824 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Total Score at Week 3 | Baseline (n=27, 22, 52) | 38.273 units on a scale | Standard Deviation 4.8715 |
| Placebo | Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Total Score at Week 3 | Change at Week 3 (n=25, 21, 48) | -6.789 units on a scale | Standard Deviation 8.5734 |
| Placebo | Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Total Score at Week 3 | Baseline (n=27, 22, 52) | 36.135 units on a scale | Standard Deviation 7.3592 |
Comparison: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.674980% CI: [-1.649, 3.2383]Mixed Models Analysis
Comparison: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.488680% CI: [-1.218, 4.0533]Mixed Models Analysis
Secondary
Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3
AIM-A: 66 item questionnaire completed by the participant to assess the impact of ADHD on the participant's quality of life. It is comprised of 4 global quality of life (QoL) items (current quality of life item \[CQoLI\], range:1 to 10; global limitation item \[GLI\]: range:1 to 4, on the right track item \[RTI\], range:1 to 3, more good days \[GD\] than bad days \[BD\], range:1 to 5, higher scores indicate a better QoL for all the 4 QoL items) and 6 multi-item subscales (living with ADHD, general well-being, performance and daily functioning \[PDF\], relationships and communication \[R/C\], Impact of symptoms-bother/concern \[IS-B/C\] scale, and impact of symptoms-interference \[IS-I\] scale). Participants responded to each item of multi-item subscale using a likert scale ranging from 1 (strongly agree) to 5 (strongly disagree). Multi-item subscale scores were calculated as an average of scores for the contributing items and transformed into 0 to 100 score where higher scores indicate a better QoL.
Time frame: Baseline, Week 3
Population: PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here 'n' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-03654746 (Low Dose) | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Change at Week 3: RTI (n=25, 21, 47) | -0.02 units on a scale | Standard Deviation 0.5492 |
| PF-03654746 (Low Dose) | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Baseline: PDF (n=27, 22, 52) | 37.176 units on a scale | Standard Deviation 15.634 |
| PF-03654746 (Low Dose) | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Baseline: CQoLI (n=27, 22, 52) | 6.481 units on a scale | Standard Deviation 1.2746 |
| PF-03654746 (Low Dose) | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Change at Week 3: GLI (n=25, 21, 47) | 0.2 units on a scale | Standard Deviation 0.4564 |
| PF-03654746 (Low Dose) | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Baseline: R/C (n=27, 22, 52) | 65.856 units on a scale | Standard Deviation 16.2652 |
| PF-03654746 (Low Dose) | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Change at Week 3: CQoLI (n=25, 21, 47) | 0.04 units on a scale | Standard Deviation 0.9456 |
| PF-03654746 (Low Dose) | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Baseline: IS-B/C (n=27, 22, 52) | 44.753 units on a scale | Standard Deviation 16.8364 |
| PF-03654746 (Low Dose) | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Baseline: More GD than BD (n=27, 22, 52) | 2.259 units on a scale | Standard Deviation 0.7642 |
| PF-03654746 (Low Dose) | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Baseline: IS-I (n=27, 22, 52) | 47.994 units on a scale | Standard Deviation 10.1284 |
| PF-03654746 (Low Dose) | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Baseline: General well-being (n=27, 22, 52) | 54.377 units on a scale | Standard Deviation 11.1639 |
| PF-03654746 (Low Dose) | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Change at Week 3: R/C (n=25, 21, 47) | 5.125 units on a scale | Standard Deviation 13.0457 |
| PF-03654746 (Low Dose) | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Baseline: RTI (n=27, 22, 52) | 1.944 units on a scale | Standard Deviation 0.5938 |
| PF-03654746 (Low Dose) | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Baseline: GLI (n=27, 22, 52) | 1.815 units on a scale | Standard Deviation 0.7091 |
| PF-03654746 (Low Dose) | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Change at Week 3: PDF (n=25, 21, 47) | 12.65 units on a scale | Standard Deviation 14.0698 |
| PF-03654746 (Low Dose) | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Change at Week 3:General well-being (n=25, 21, 47) | 4.909 units on a scale | Standard Deviation 7.1999 |
| PF-03654746 (Low Dose) | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Change at Week 3: Living with ADHD (n=25, 21, 47) | 2.55 units on a scale | Standard Deviation 4.5712 |
| PF-03654746 (Low Dose) | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Baseline: Living with ADHD (n=27, 22, 52) | 53.935 units on a scale | Standard Deviation 9.587 |
| PF-03654746 (Low Dose) | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Change at Week 3: IS-I (n=25, 21, 47) | 2.389 units on a scale | Standard Deviation 8.2023 |
| PF-03654746 (Low Dose) | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Change at Week 3: More GD than BD (n=25, 21, 47) | -0.32 units on a scale | Standard Deviation 0.6272 |
| PF-03654746 (Low Dose) | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Change at Week 3: IS-B/C (n=25, 21, 47) | 3 units on a scale | Standard Deviation 12.9465 |
| PF-03654746 (Flexible Dose) | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Baseline: More GD than BD (n=27, 22, 52) | 2.682 units on a scale | Standard Deviation 0.8803 |
| PF-03654746 (Flexible Dose) | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Baseline: R/C (n=27, 22, 52) | 57.955 units on a scale | Standard Deviation 15.7281 |
| PF-03654746 (Flexible Dose) | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Baseline: CQoLI (n=27, 22, 52) | 6.409 units on a scale | Standard Deviation 1.1406 |
| PF-03654746 (Flexible Dose) | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Baseline: GLI (n=27, 22, 52) | 1.705 units on a scale | Standard Deviation 0.7505 |
| PF-03654746 (Flexible Dose) | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Baseline: RTI (n=27, 22, 52) | 2.068 units on a scale | Standard Deviation 0.3872 |
| PF-03654746 (Flexible Dose) | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Baseline: Living with ADHD (n=27, 22, 52) | 49.773 units on a scale | Standard Deviation 12.4202 |
| PF-03654746 (Flexible Dose) | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Baseline: General well-being (n=27, 22, 52) | 50.413 units on a scale | Standard Deviation 17.2322 |
| PF-03654746 (Flexible Dose) | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Baseline: PDF (n=27, 22, 52) | 34.489 units on a scale | Standard Deviation 15.3756 |
| PF-03654746 (Flexible Dose) | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Baseline: IS-B/C (n=27, 22, 52) | 42.235 units on a scale | Standard Deviation 19.7475 |
| PF-03654746 (Flexible Dose) | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Baseline: IS-I (n=27, 22, 52) | 46.78 units on a scale | Standard Deviation 9.1366 |
| PF-03654746 (Flexible Dose) | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Change at Week 3: CQoLI (n=25, 21, 47) | 0.286 units on a scale | Standard Deviation 1.2306 |
| PF-03654746 (Flexible Dose) | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Change at Week 3: GLI (n=25, 21, 47) | 0.214 units on a scale | Standard Deviation 0.7676 |
| PF-03654746 (Flexible Dose) | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Change at Week 3: RTI (n=25, 21, 47) | -0.071 units on a scale | Standard Deviation 0.6381 |
| PF-03654746 (Flexible Dose) | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Change at Week 3: More GD than BD (n=25, 21, 47) | -0.238 units on a scale | Standard Deviation 0.9826 |
| PF-03654746 (Flexible Dose) | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Change at Week 3: Living with ADHD (n=25, 21, 47) | 1.905 units on a scale | Standard Deviation 5.5145 |
| PF-03654746 (Flexible Dose) | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Change at Week 3:General well-being (n=25, 21, 47) | 1.299 units on a scale | Standard Deviation 8.9642 |
| PF-03654746 (Flexible Dose) | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Change at Week 3: PDF (n=25, 21, 47) | 11.488 units on a scale | Standard Deviation 21.7501 |
| PF-03654746 (Flexible Dose) | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Change at Week 3: R/C (n=25, 21, 47) | 0.298 units on a scale | Standard Deviation 16.3773 |
| PF-03654746 (Flexible Dose) | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Change at Week 3: IS-B/C (n=25, 21, 47) | 0.463 units on a scale | Standard Deviation 18.6097 |
| PF-03654746 (Flexible Dose) | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Change at Week 3: IS-I (n=25, 21, 47) | 0.463 units on a scale | Standard Deviation 9.3204 |
| Placebo | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Baseline: Living with ADHD (n=27, 22, 52) | 51.058 units on a scale | Standard Deviation 10.5294 |
| Placebo | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Change at Week 3: R/C (n=25, 21, 47) | 3.358 units on a scale | Standard Deviation 13.4687 |
| Placebo | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Baseline: More GD than BD (n=27, 22, 52) | 2.529 units on a scale | Standard Deviation 0.8069 |
| Placebo | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Change at Week 3: More GD than BD (n=25, 21, 47) | -0.106 units on a scale | Standard Deviation 0.9997 |
| Placebo | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Change at Week 3: Living with ADHD (n=25, 21, 47) | 3.005 units on a scale | Standard Deviation 7.2121 |
| Placebo | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Baseline: CQoLI (n=27, 22, 52) | 6.423 units on a scale | Standard Deviation 1.1219 |
| Placebo | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Change at Week 3: IS-I (n=25, 21, 47) | 2.896 units on a scale | Standard Deviation 10.6124 |
| Placebo | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Change at Week 3:General well-being (n=25, 21, 47) | 4.884 units on a scale | Standard Deviation 10.3145 |
| Placebo | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Baseline: RTI (n=27, 22, 52) | 1.99 units on a scale | Standard Deviation 0.4999 |
| Placebo | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Change at Week 3: IS-B/C (n=25, 21, 47) | 7.417 units on a scale | Standard Deviation 13.7471 |
| Placebo | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Baseline: IS-I (n=27, 22, 52) | 46.768 units on a scale | Standard Deviation 8.8729 |
| Placebo | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Baseline: R/C (n=27, 22, 52) | 61.358 units on a scale | Standard Deviation 14.7036 |
| Placebo | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Change at Week 3: PDF (n=25, 21, 47) | 10.718 units on a scale | Standard Deviation 18.3226 |
| Placebo | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Change at Week 3: CQoLI (n=25, 21, 47) | 0.17 units on a scale | Standard Deviation 1.3116 |
| Placebo | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Baseline: PDF (n=27, 22, 52) | 34.688 units on a scale | Standard Deviation 13.5081 |
| Placebo | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Baseline: GLI (n=27, 22, 52) | 1.663 units on a scale | Standard Deviation 0.624 |
| Placebo | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Change at Week 3: GLI (n=25, 21, 47) | 0.106 units on a scale | Standard Deviation 0.6421 |
| Placebo | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Baseline: General well-being (n=27, 22, 52) | 50.83 units on a scale | Standard Deviation 13.2045 |
| Placebo | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Baseline: IS-B/C (n=27, 22, 52) | 42.201 units on a scale | Standard Deviation 16.7033 |
| Placebo | Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 | Change at Week 3: RTI (n=25, 21, 47) | -0.074 units on a scale | Standard Deviation 0.5612 |
Comparison: Week 3 (CQoL): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.741580% CI: [-0.4892, 0.29012]Mixed Models Analysis
Comparison: Week 3 (CQoL): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.882280% CI: [-0.3703, 0.4664]Mixed Models Analysis
Comparison: Week 3 (GLI): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.341480% CI: [-0.0439, 0.29385]Mixed Models Analysis
Comparison: Week 3 (GLI): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.464280% CI: [-0.0793, 0.28814]Mixed Models Analysis
Comparison: Week 3 (RTI): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.504980% CI: [-0.0571, 0.17926]Mixed Models Analysis
Comparison: Week 3 (RTI): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.433280% CI: [-0.051, 0.2093]Mixed Models Analysis
Comparison: Week 3 (More GD than BD): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.167880% CI: [-0.473, -0.0177]Mixed Models Analysis
Comparison: Week 3 (More GD than BD): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.690180% CI: [-0.1726, 0.32695]Mixed Models Analysis
Comparison: Week 3 (Living with ADHD): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.900580% CI: [-1.587, 1.9274]Mixed Models Analysis
Comparison: Week 3 (Living with ADHD): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.33380% CI: [-3.333, 0.46937]Mixed Models Analysis
Comparison: Week 3 (General well-being): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.755180% CI: [-2.051, 3.3584]Mixed Models Analysis
Comparison: Week 3 (General well-being): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.033480% CI: [-7.759, -1.968]Mixed Models Analysis
Comparison: Week 3 (PDF): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.651980% CI: [-3.05, 6.3281]Mixed Models Analysis
Comparison: Week 3 (PDF): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.763180% CI: [-3.941, 6.3423]Mixed Models Analysis
Comparison: Week 3 (R/C): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.303480% CI: [-0.7227, 6.5648]Mixed Models Analysis
Comparison: Week 3 (R/C): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.093380% CI: [-8.975, -1.218]Mixed Models Analysis
Comparison: Week 3 (IS-B/C): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.094980% CI: [-8.934, -1.201]Mixed Models Analysis
Comparison: Week 3 (IS-B/C): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.028380% CI: [-11.55, -3.106]Mixed Models Analysis
Comparison: Week 3 (IS-I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.185280% CI: [-4.229, -0.0719]Mixed Models Analysis
Comparison: Week 3 (IS-I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.162380% CI: [-4.823, -0.2127]Mixed Models Analysis
Secondary
Change From Baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) Subscale Scores at Week 1, 2 and 3
AISRS: an 18-item scale administered by the investigator. It included 9 items that evaluated symptoms of inattention and 9 items that evaluated symptoms of impulsivity and hyperactivity. Each item was rated from 0 (none) to 3 (severe). The AISRS inattention and hyperactive/impulsive total subscale score range from 0 to 27. A higher total subscale score corresponded to a worse severity of ADHD inattention or hyperactivity/impulsivity.
Time frame: Baseline, Week 1, 2, 3
Population: PP analysis set:all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-03654746 (Low Dose) | Change From Baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) Subscale Scores at Week 1, 2 and 3 | Week 2: Hyperactivity/Impulsivity (n=23, 20, 46) | -1.696 units on a scale | Standard Deviation 3.1935 |
| PF-03654746 (Low Dose) | Change From Baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) Subscale Scores at Week 1, 2 and 3 | Week 1: Inattention (n=26, 22, 50) | -3.423 units on a scale | Standard Deviation 3.6241 |
| PF-03654746 (Low Dose) | Change From Baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) Subscale Scores at Week 1, 2 and 3 | Week 3: Hyperactivity/Impulsivity (n=25, 21, 48) | -3.111 units on a scale | Standard Deviation 4.1894 |
| PF-03654746 (Low Dose) | Change From Baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) Subscale Scores at Week 1, 2 and 3 | Week 3: Inattention (n=25, 21, 48) | -4.085 units on a scale | Standard Deviation 5.7909 |
| PF-03654746 (Low Dose) | Change From Baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) Subscale Scores at Week 1, 2 and 3 | Week 2: Inattention (n=23, 20, 46) | -4.326 units on a scale | Standard Deviation 5.2627 |
| PF-03654746 (Low Dose) | Change From Baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) Subscale Scores at Week 1, 2 and 3 | Week 1: Hyperactivity/Impulsivity (n=26, 22, 50) | -1.519 units on a scale | Standard Deviation 3.708 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) Subscale Scores at Week 1, 2 and 3 | Week 2: Inattention (n=23, 20, 46) | -2.65 units on a scale | Standard Deviation 4.5541 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) Subscale Scores at Week 1, 2 and 3 | Week 1: Hyperactivity/Impulsivity (n=26, 22, 50) | -1.955 units on a scale | Standard Deviation 4.0027 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) Subscale Scores at Week 1, 2 and 3 | Week 2: Hyperactivity/Impulsivity (n=23, 20, 46) | -3.05 units on a scale | Standard Deviation 3.9766 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) Subscale Scores at Week 1, 2 and 3 | Week 3: Hyperactivity/Impulsivity (n=25, 21, 48) | -2.435 units on a scale | Standard Deviation 4.8666 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) Subscale Scores at Week 1, 2 and 3 | Week 1: Inattention (n=26, 22, 50) | -1.636 units on a scale | Standard Deviation 4.7338 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) Subscale Scores at Week 1, 2 and 3 | Week 3: Inattention (n=25, 21, 48) | -3.31 units on a scale | Standard Deviation 5.8019 |
| Placebo | Change From Baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) Subscale Scores at Week 1, 2 and 3 | Week 3: Hyperactivity/Impulsivity (n=25, 21, 48) | -3.07 units on a scale | Standard Deviation 4.2411 |
| Placebo | Change From Baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) Subscale Scores at Week 1, 2 and 3 | Week 2: Inattention (n=23, 20, 46) | -4.022 units on a scale | Standard Deviation 4.2985 |
| Placebo | Change From Baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) Subscale Scores at Week 1, 2 and 3 | Week 1: Hyperactivity/Impulsivity (n=26, 22, 50) | -2.164 units on a scale | Standard Deviation 3.7001 |
| Placebo | Change From Baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) Subscale Scores at Week 1, 2 and 3 | Week 1: Inattention (n=26, 22, 50) | -3.36 units on a scale | Standard Deviation 4.3986 |
| Placebo | Change From Baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) Subscale Scores at Week 1, 2 and 3 | Week 3: Inattention (n=25, 21, 48) | -3.719 units on a scale | Standard Deviation 5.195 |
| Placebo | Change From Baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) Subscale Scores at Week 1, 2 and 3 | Week 2: Hyperactivity/Impulsivity (n=23, 20, 46) | -3.087 units on a scale | Standard Deviation 3.2614 |
Comparison: Week 1 (Inattention): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.870880% CI: [-1.162, 1.4971]Mixed Models Analysis
Comparison: Week 1 (Inattention): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.092780% CI: [0.44874, 3.2726]Mixed Models Analysis
Comparison: Week 1 (Hyperactivity/Impulsivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.340580% CI: [-0.3008, 2.0329]Mixed Models Analysis
Comparison: Week 1 (Hyperactivity/Impulsivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.866580% CI: [-1.08, 1.4047]Mixed Models Analysis
Comparison: Week 2 (Inattention): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.690180% CI: [-0.8694, 1.6466]Mixed Models Analysis
Comparison: Week 2 (Inattention): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.17980% CI: [0.06498, 2.6908]Mixed Models Analysis
Comparison: Week 2 (Hyperactivity/Impulsivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.015680% CI: [0.90156, 2.8502]Mixed Models Analysis
Comparison: Week 2 (Hyperactivity/Impulsivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.957380% CI: [-1.06, 0.97559]Mixed Models Analysis
Comparison: Week 3 (Inattention): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.898680% CI: [-1.462, 1.782]Mixed Models Analysis
Comparison: Week 3 (Inattention): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.620480% CI: [-1.071, 2.4086]Mixed Models Analysis
Comparison: Week 3 (Hyperactivity/Impulsivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.575980% CI: [-0.6421, 1.6261]Mixed Models Analysis
Comparison: Week 3 (Hyperactivity/Impulsivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.360380% CI: [-0.3552, 2.1051]Mixed Models Analysis
Secondary
Change From Baseline in Adult ADHD Quality of Life Scale (AAQOL) Subscale Score at Week 3
AAQoL is a 29-item questionnaire consisting of 4 subscales: life productivity (11 items), psychological health (\[PH\] 6 items), life outlook (7 items) and relationships (5 items). Participants rated each item on a scale ranging from 1 (not at all/never) to 5 (extremely/very often). The scores of each item were then transformed to a 0 to 100 point scale, higher scores indicating better quality of life. The score for each subscale was calculated as the sum of the corresponding item scores. Total score ranges were: life productivity (0 to 1100), psychological health (0 to 600), life outlook (0 to 700) and relationships (0 to 500), where higher subscale score indicates better quality of life for each subscale.
Time frame: Baseline, Week 3
Population: PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here 'n' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-03654746 (Low Dose) | Change From Baseline in Adult ADHD Quality of Life Scale (AAQOL) Subscale Score at Week 3 | Change at Week 3: Relationships (n=25, 21, 47) | -1.5 units on a scale | Standard Deviation 31.9342 |
| PF-03654746 (Low Dose) | Change From Baseline in Adult ADHD Quality of Life Scale (AAQOL) Subscale Score at Week 3 | Change at Week 3: PH (n=25, 21, 47) | 0 units on a scale | Standard Deviation 50.5181 |
| PF-03654746 (Low Dose) | Change From Baseline in Adult ADHD Quality of Life Scale (AAQOL) Subscale Score at Week 3 | Baseline: Life productivity (n=27, 22, 52) | 306.481 units on a scale | Standard Deviation 109.9809 |
| PF-03654746 (Low Dose) | Change From Baseline in Adult ADHD Quality of Life Scale (AAQOL) Subscale Score at Week 3 | Change at Week 3: Life outlook (n=25, 21, 47) | -13 units on a scale | Standard Deviation 56.9951 |
| PF-03654746 (Low Dose) | Change From Baseline in Adult ADHD Quality of Life Scale (AAQOL) Subscale Score at Week 3 | Baseline: Psychological health (n=27, 22, 52) | 163.889 units on a scale | Standard Deviation 42.9296 |
| PF-03654746 (Low Dose) | Change From Baseline in Adult ADHD Quality of Life Scale (AAQOL) Subscale Score at Week 3 | Baseline: Life outlook (n=27, 22, 52) | 229.63 units on a scale | Standard Deviation 65.7929 |
| PF-03654746 (Low Dose) | Change From Baseline in Adult ADHD Quality of Life Scale (AAQOL) Subscale Score at Week 3 | Baseline: Relationships (n=27, 22, 52) | 152.778 units on a scale | Standard Deviation 49.1922 |
| PF-03654746 (Low Dose) | Change From Baseline in Adult ADHD Quality of Life Scale (AAQOL) Subscale Score at Week 3 | Change at Week 3: Life productivity (n=25, 21, 47) | 3 units on a scale | Standard Deviation 84.1068 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Adult ADHD Quality of Life Scale (AAQOL) Subscale Score at Week 3 | Baseline: Relationships (n=27, 22, 52) | 154.545 units on a scale | Standard Deviation 46.0566 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Adult ADHD Quality of Life Scale (AAQOL) Subscale Score at Week 3 | Change at Week 3: Life productivity (n=25, 21, 47) | 8.333 units on a scale | Standard Deviation 112.7312 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Adult ADHD Quality of Life Scale (AAQOL) Subscale Score at Week 3 | Change at Week 3: Relationships (n=25, 21, 47) | 1.19 units on a scale | Standard Deviation 46.2508 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Adult ADHD Quality of Life Scale (AAQOL) Subscale Score at Week 3 | Baseline: Psychological health (n=27, 22, 52) | 146.591 units on a scale | Standard Deviation 66.0517 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Adult ADHD Quality of Life Scale (AAQOL) Subscale Score at Week 3 | Change at Week 3: PH (n=25, 21, 47) | 1.786 units on a scale | Standard Deviation 57.1847 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Adult ADHD Quality of Life Scale (AAQOL) Subscale Score at Week 3 | Baseline: Life outlook (n=27, 22, 52) | 194.318 units on a scale | Standard Deviation 69.8348 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Adult ADHD Quality of Life Scale (AAQOL) Subscale Score at Week 3 | Change at Week 3: Life outlook (n=25, 21, 47) | 14.286 units on a scale | Standard Deviation 68.9526 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Adult ADHD Quality of Life Scale (AAQOL) Subscale Score at Week 3 | Baseline: Life productivity (n=27, 22, 52) | 292.045 units on a scale | Standard Deviation 72.5334 |
| Placebo | Change From Baseline in Adult ADHD Quality of Life Scale (AAQOL) Subscale Score at Week 3 | Change at Week 3: Relationships (n=25, 21, 47) | -3.723 units on a scale | Standard Deviation 45.662 |
| Placebo | Change From Baseline in Adult ADHD Quality of Life Scale (AAQOL) Subscale Score at Week 3 | Change at Week 3: Life outlook (n=25, 21, 47) | -8.511 units on a scale | Standard Deviation 42.6776 |
| Placebo | Change From Baseline in Adult ADHD Quality of Life Scale (AAQOL) Subscale Score at Week 3 | Baseline: Psychological health (n=27, 22, 52) | 167.788 units on a scale | Standard Deviation 59.4782 |
| Placebo | Change From Baseline in Adult ADHD Quality of Life Scale (AAQOL) Subscale Score at Week 3 | Baseline: Life outlook (n=27, 22, 52) | 218.269 units on a scale | Standard Deviation 59.0188 |
| Placebo | Change From Baseline in Adult ADHD Quality of Life Scale (AAQOL) Subscale Score at Week 3 | Baseline: Relationships (n=27, 22, 52) | 163.942 units on a scale | Standard Deviation 49.856 |
| Placebo | Change From Baseline in Adult ADHD Quality of Life Scale (AAQOL) Subscale Score at Week 3 | Change at Week 3: Life productivity (n=25, 21, 47) | 22.606 units on a scale | Standard Deviation 85.7606 |
| Placebo | Change From Baseline in Adult ADHD Quality of Life Scale (AAQOL) Subscale Score at Week 3 | Change at Week 3: PH (n=25, 21, 47) | 11.436 units on a scale | Standard Deviation 63.9415 |
| Placebo | Change From Baseline in Adult ADHD Quality of Life Scale (AAQOL) Subscale Score at Week 3 | Baseline: Life productivity (n=27, 22, 52) | 281.25 units on a scale | Standard Deviation 107.9982 |
Comparison: Week 3 (Life productivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.524180% CI: [-35.02, 11.86]Mixed Models Analysis
Comparison: Week 3 (Life productivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.306580% CI: [-45.89, 5.2183]Mixed Models Analysis
Comparison: Week 3 (Psychological health): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.383180% CI: [-29.15, 5.5793]Mixed Models Analysis
Comparison: Week 3 (Psychological health): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.365780% CI: [-31.8, 5.5241]Mixed Models Analysis
Comparison: Week 3 (Life outlook): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.818880% CI: [-12.36, 17.69]Mixed Models Analysis
Comparison: Week 3 (Life outlook): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.056680% CI: [8.0305, 40.172]Mixed Models Analysis
Comparison: Week 3 (Relationships): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.931280% CI: [-10.55, 12.057]Mixed Models Analysis
Comparison: Week 3 (Relationships): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.519480% CI: [-6.108, 18.336]Mixed Models Analysis
Secondary
Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Total Score at Week 1 and 2
AISRS: an 18-item scale administered by the investigator. It included 9 items that evaluated symptoms of inattention and 9 items that evaluated symptoms of impulsivity and hyperactivity. Each item was rated from 0 (none) to 3 (severe). AISRS total score was calculated as sum of all the items on the scale and ranged from 0 to 54. A higher score corresponded to a worse severity of ADHD.
Time frame: Baseline, Week 1, 2
Population: PP analysis set:all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-03654746 (Low Dose) | Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Total Score at Week 1 and 2 | Week 1 (n=26, 22, 50) | -4.942 units on a scale | Standard Deviation 6.2005 |
| PF-03654746 (Low Dose) | Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Total Score at Week 1 and 2 | Week 2 (n=23, 20, 46) | -6.022 units on a scale | Standard Deviation 7.1486 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Total Score at Week 1 and 2 | Week 2 (n=23, 20, 46) | -5.7 units on a scale | Standard Deviation 7.8143 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Total Score at Week 1 and 2 | Week 1 (n=26, 22, 50) | -3.591 units on a scale | Standard Deviation 8.3476 |
| Placebo | Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Total Score at Week 1 and 2 | Week 1 (n=26, 22, 50) | -5.524 units on a scale | Standard Deviation 7.4545 |
| Placebo | Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Total Score at Week 1 and 2 | Week 2 (n=23, 20, 46) | -7.109 units on a scale | Standard Deviation 6.6139 |
Comparison: Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.564380% CI: [-1.262, 3.3121]Mixed Models Analysis
Comparison: Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.310780% CI: [-0.51, 4.3392]Mixed Models Analysis
Comparison: Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.119680% CI: [0.41601, 4.2148]Mixed Models Analysis
Comparison: Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.387280% CI: [-0.649, 3.3065]Mixed Models Analysis
Secondary
Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Week 3
HAM-A is a clinician-rated 14 item scale that provides an overall measure of global anxiety, including psychic (mental agitation and psychological distress) and somatic (physical complaints related to anxiety) symptoms. Each item was scored on a scale ranging from 0 (not present) to 4 (very severe) with a total score range of 0 to 56, where higher score indicates greater anxiety.
Time frame: Baseline, Week 3
Population: PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here 'n' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-03654746 (Low Dose) | Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Week 3 | Baseline (n=27, 22, 52) | 5.333 units on a scale | Standard Deviation 3.9223 |
| PF-03654746 (Low Dose) | Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Week 3 | Change at Week 3 (n=18, 21, 39) | -0.944 units on a scale | Standard Deviation 2.514 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Week 3 | Baseline (n=27, 22, 52) | 6.045 units on a scale | Standard Deviation 3.848 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Week 3 | Change at Week 3 (n=18, 21, 39) | -0.19 units on a scale | Standard Deviation 2.5518 |
| Placebo | Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Week 3 | Baseline (n=27, 22, 52) | 5.327 units on a scale | Standard Deviation 3.3238 |
| Placebo | Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Week 3 | Change at Week 3 (n=18, 21, 39) | -0.487 units on a scale | Standard Deviation 2.7732 |
Comparison: Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.546680% CI: [-1.313, 0.47668]Mixed Models Analysis
Comparison: Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.970580% CI: [-0.9035, 0.85312]Mixed Models Analysis
Secondary
Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at Week 3
The MADRS scale measures the depression level of a participant. It is administered as a semi-structured clinician interview. The total score is derived by adding the scores of the following 10 items: (1) Apparent sadness; (2) Reported sadness; (3) Inner tension; (4) Reduced sleep; (5) Reduced appetite; (6) Concentration difficulties; (7) Lassitude; (8) Inability to feel; (9) Pessimistic thoughts; (10) Suicidal thoughts. Each item is scored using a 6-point scale which ranges from 0 to 6 (a higher score indicates increased severity). The total score range was 0 to 60 where 0 indicates no depression and 60 indicates severely depressed.
Time frame: Baseline, Week 3
Population: PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here 'n' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-03654746 (Low Dose) | Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at Week 3 | Baseline (n=27, 22, 52) | 6.63 units on a scale | Standard Deviation 3.9918 |
| PF-03654746 (Low Dose) | Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at Week 3 | Change at Week 3 (n=21, 19, 42) | -2.19 units on a scale | Standard Deviation 3.9353 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at Week 3 | Baseline (n=27, 22, 52) | 7.773 units on a scale | Standard Deviation 5.0231 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at Week 3 | Change at Week 3 (n=21, 19, 42) | -1.289 units on a scale | Standard Deviation 3.728 |
| Placebo | Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at Week 3 | Change at Week 3 (n=21, 19, 42) | -0.524 units on a scale | Standard Deviation 5.1572 |
| Placebo | Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at Week 3 | Baseline (n=27, 22, 52) | 6.962 units on a scale | Standard Deviation 4.5631 |
Comparison: Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.091380% CI: [-2.643, -0.3705]Mixed Models Analysis
Comparison: Day 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.821680% CI: [-1.399, 0.98326]Mixed Models Analysis
Secondary
Change From Baseline in Sheehan Disability Scale (SDS) Subscale Scores at Week 3
SDS was a participant-rated questionnaire assessing the effect of the participant's symptoms on the 3 domains/subscales: work/school, social life/leisure activities, and family/home management. Each domain was rated on visual analog scale ranges from 0 to 10 where 0=not at all impaired and 10=extremely impaired, and total SDS score was calculated as a sum of all the domains with a score range of 0=not at all impaired to 30=extremely impaired. Disability scores were reported for each of the domains/subscales. Higher scores reflect greater impairment.
Time frame: Baseline, Week 3
Population: PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here 'n' signifies those participants who were evaluable for given subscale at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-03654746 (Low Dose) | Change From Baseline in Sheehan Disability Scale (SDS) Subscale Scores at Week 3 | Baseline: Work/school (n=26, 21, 50) | 6.058 units on a scale | Standard Deviation 2.2375 |
| PF-03654746 (Low Dose) | Change From Baseline in Sheehan Disability Scale (SDS) Subscale Scores at Week 3 | Change at Week 3: Family life/home (n=25, 21, 47) | -0.78 units on a scale | Standard Deviation 1.5618 |
| PF-03654746 (Low Dose) | Change From Baseline in Sheehan Disability Scale (SDS) Subscale Scores at Week 3 | Baseline: Social life (n=27, 22, 52) | 4.593 units on a scale | Standard Deviation 2.0383 |
| PF-03654746 (Low Dose) | Change From Baseline in Sheehan Disability Scale (SDS) Subscale Scores at Week 3 | Baseline: Family life/home (n=27, 22, 52) | 5.019 units on a scale | Standard Deviation 2.0357 |
| PF-03654746 (Low Dose) | Change From Baseline in Sheehan Disability Scale (SDS) Subscale Scores at Week 3 | Change at Week 3: Work/school (n=24, 18, 45) | -0.813 units on a scale | Standard Deviation 1.3089 |
| PF-03654746 (Low Dose) | Change From Baseline in Sheehan Disability Scale (SDS) Subscale Scores at Week 3 | Change at Week 3: Social life (n=25, 21, 47) | -0.8 units on a scale | Standard Deviation 1.75 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Sheehan Disability Scale (SDS) Subscale Scores at Week 3 | Change at Week 3: Family life/home (n=25, 21, 47) | -0.071 units on a scale | Standard Deviation 2.2709 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Sheehan Disability Scale (SDS) Subscale Scores at Week 3 | Baseline: Social life (n=27, 22, 52) | 5.227 units on a scale | Standard Deviation 2.5153 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Sheehan Disability Scale (SDS) Subscale Scores at Week 3 | Change at Week 3: Work/school (n=24, 18, 45) | -0.222 units on a scale | Standard Deviation 2.2572 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Sheehan Disability Scale (SDS) Subscale Scores at Week 3 | Baseline: Family life/home (n=27, 22, 52) | 5.705 units on a scale | Standard Deviation 2.0393 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Sheehan Disability Scale (SDS) Subscale Scores at Week 3 | Baseline: Work/school (n=26, 21, 50) | 6.095 units on a scale | Standard Deviation 2.0894 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Sheehan Disability Scale (SDS) Subscale Scores at Week 3 | Change at Week 3: Social life (n=25, 21, 47) | -0.619 units on a scale | Standard Deviation 2.4592 |
| Placebo | Change From Baseline in Sheehan Disability Scale (SDS) Subscale Scores at Week 3 | Change at Week 3: Social life (n=25, 21, 47) | -0.436 units on a scale | Standard Deviation 1.9043 |
| Placebo | Change From Baseline in Sheehan Disability Scale (SDS) Subscale Scores at Week 3 | Baseline: Work/school (n=26, 21, 50) | 6.36 units on a scale | Standard Deviation 1.977 |
| Placebo | Change From Baseline in Sheehan Disability Scale (SDS) Subscale Scores at Week 3 | Change at Week 3: Work/school (n=24, 18, 45) | -0.411 units on a scale | Standard Deviation 1.7526 |
| Placebo | Change From Baseline in Sheehan Disability Scale (SDS) Subscale Scores at Week 3 | Baseline: Family life/home (n=27, 22, 52) | 5.673 units on a scale | Standard Deviation 1.8335 |
| Placebo | Change From Baseline in Sheehan Disability Scale (SDS) Subscale Scores at Week 3 | Baseline: Social life (n=27, 22, 52) | 5.01 units on a scale | Standard Deviation 2.0757 |
| Placebo | Change From Baseline in Sheehan Disability Scale (SDS) Subscale Scores at Week 3 | Change at Week 3: Family life/home (n=25, 21, 47) | -0.532 units on a scale | Standard Deviation 1.6596 |
Comparison: Week 3 (Work/school): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.33280% CI: [-0.7573, 0.10622]Mixed Models Analysis
Comparison: Week 3 (Work/school): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.276780% CI: [-0.0769, 0.92804]Mixed Models Analysis
Comparison: Week 3 (Social life): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.367580% CI: [-0.8887, 0.1566]Mixed Models Analysis
Comparison: Week 3 (Social life): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.814180% CI: [-0.67, 0.46345]Mixed Models Analysis
Comparison: Week 3 (Family life/home): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.618680% CI: [-0.6657, 0.29495]Mixed Models Analysis
Comparison: Week 3 (Family life/home): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.37280% CI: [-0.1597, 0.88432]Mixed Models Analysis
Secondary
Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score on Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 21
TASS: a time sensitive 18-item questionnaire completed by the participant that measured the severity of current ADHD symptoms. It included 9 items that evaluate symptoms of inattention sub-scale and 9 items that evaluate symptoms of impulsivity and hyperactivity sub-scale. Each item was rated from 0 (none) to 3 (severe). TASS total score was calculated as sum of all the items on the scale and ranged from 0 to 54. A higher total score corresponded to a worse severity of ADHD. TASS was administered each day from Day 1 to 14 and on Day 21 in each intervention period.
Time frame: Baseline, Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 21
Population: Analysis population included all participants in PP analysis set and 1 additional participant in PF-03654746 (Flexible Dose) for whom the post-baseline data was available.'N' (number of participants analyzed)=evaluable participants for this measure and 'n'= evaluable participants for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-03654746 (Low Dose) | Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score on Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 21 | Day 21 (n=9, 6, 22) | -9.889 units on a scale | Standard Deviation 7.474 |
| PF-03654746 (Low Dose) | Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score on Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 21 | Day 9 (n=21, 18, 45) | -4.238 units on a scale | Standard Deviation 6.1352 |
| PF-03654746 (Low Dose) | Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score on Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 21 | Day 4 (n=26, 22, 46) | -4.981 units on a scale | Standard Deviation 8.8346 |
| PF-03654746 (Low Dose) | Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score on Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 21 | Day 13 (n=22, 19, 43) | -6.091 units on a scale | Standard Deviation 6.4284 |
| PF-03654746 (Low Dose) | Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score on Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 21 | Day 8 (n=21, 19, 46) | -5.952 units on a scale | Standard Deviation 7.0709 |
| PF-03654746 (Low Dose) | Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score on Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 21 | Day 5 (n=26, 23, 49) | -4.942 units on a scale | Standard Deviation 7.7153 |
| PF-03654746 (Low Dose) | Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score on Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 21 | Day 1 (n=25, 22, 50) | -0.46 units on a scale | Standard Deviation 5.3384 |
| PF-03654746 (Low Dose) | Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score on Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 21 | Day 7 (n=21, 18, 45) | -6.381 units on a scale | Standard Deviation 7.7619 |
| PF-03654746 (Low Dose) | Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score on Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 21 | Day 6 (n=27, 22, 44) | -5.833 units on a scale | Standard Deviation 7.3183 |
| PF-03654746 (Low Dose) | Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score on Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 21 | Day 12 (n=20, 18, 44) | -6.45 units on a scale | Standard Deviation 7.3947 |
| PF-03654746 (Low Dose) | Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score on Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 21 | Day 11 (n=21, 20, 46) | -5.619 units on a scale | Standard Deviation 6.7341 |
| PF-03654746 (Low Dose) | Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score on Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 21 | Day 2 (n=25, 21, 49) | -1.78 units on a scale | Standard Deviation 6.8679 |
| PF-03654746 (Low Dose) | Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score on Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 21 | Day 14 (n=17, 16, 35) | -5.147 units on a scale | Standard Deviation 6.7818 |
| PF-03654746 (Low Dose) | Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score on Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 21 | Day 10 (n=20, 20, 46) | -5.75 units on a scale | Standard Deviation 6.9689 |
| PF-03654746 (Low Dose) | Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score on Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 21 | Day 3 (n=26, 21, 49) | -2.798 units on a scale | Standard Deviation 12.1305 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score on Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 21 | Day 7 (n=21, 18, 45) | -6.222 units on a scale | Standard Deviation 11.2736 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score on Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 21 | Day 11 (n=21, 20, 46) | -5.875 units on a scale | Standard Deviation 11.2377 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score on Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 21 | Day 14 (n=17, 16, 35) | -7.5 units on a scale | Standard Deviation 11.0559 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score on Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 21 | Day 21 (n=9, 6, 22) | -4.583 units on a scale | Standard Deviation 8.4346 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score on Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 21 | Day 1 (n=25, 22, 50) | 2.205 units on a scale | Standard Deviation 14.9217 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score on Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 21 | Day 2 (n=25, 21, 49) | -0.952 units on a scale | Standard Deviation 13.4433 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score on Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 21 | Day 3 (n=26, 21, 49) | -3.857 units on a scale | Standard Deviation 10.0476 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score on Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 21 | Day 4 (n=26, 22, 46) | -1.068 units on a scale | Standard Deviation 14.4018 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score on Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 21 | Day 5 (n=26, 23, 49) | -1.87 units on a scale | Standard Deviation 10.2239 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score on Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 21 | Day 6 (n=27, 22, 44) | -3.205 units on a scale | Standard Deviation 10.5984 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score on Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 21 | Day 8 (n=21, 19, 46) | -6.526 units on a scale | Standard Deviation 9.7389 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score on Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 21 | Day 9 (n=21, 18, 45) | -5.889 units on a scale | Standard Deviation 9.9979 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score on Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 21 | Day 10 (n=20, 20, 46) | -7.525 units on a scale | Standard Deviation 9.6579 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score on Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 21 | Day 12 (n=20, 18, 44) | -6.167 units on a scale | Standard Deviation 10.3099 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score on Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 21 | Day 13 (n=22, 19, 43) | -5.658 units on a scale | Standard Deviation 11.024 |
| Placebo | Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score on Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 21 | Day 3 (n=26, 21, 49) | -3.51 units on a scale | Standard Deviation 10.3282 |
| Placebo | Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score on Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 21 | Day 21 (n=9, 6, 22) | -8.295 units on a scale | Standard Deviation 8.299 |
| Placebo | Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score on Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 21 | Day 9 (n=21, 18, 45) | -5.889 units on a scale | Standard Deviation 10.8664 |
| Placebo | Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score on Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 21 | Day 2 (n=25, 21, 49) | -6.031 units on a scale | Standard Deviation 10.2938 |
| Placebo | Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score on Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 21 | Day 14 (n=17, 16, 35) | -2.506 units on a scale | Standard Deviation 25.19 |
| Placebo | Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score on Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 21 | Day 10 (n=20, 20, 46) | -6.837 units on a scale | Standard Deviation 10.7755 |
| Placebo | Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score on Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 21 | Day 1 (n=25, 22, 50) | -4.75 units on a scale | Standard Deviation 6.7221 |
| Placebo | Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score on Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 21 | Day 13 (n=22, 19, 43) | -7.488 units on a scale | Standard Deviation 7.9279 |
| Placebo | Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score on Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 21 | Day 7 (n=21, 18, 45) | -4.789 units on a scale | Standard Deviation 9.7044 |
| Placebo | Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score on Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 21 | Day 12 (n=20, 18, 44) | -6.295 units on a scale | Standard Deviation 10.3622 |
| Placebo | Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score on Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 21 | Day 6 (n=27, 22, 44) | -6.841 units on a scale | Standard Deviation 9.9573 |
| Placebo | Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score on Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 21 | Day 5 (n=26, 23, 49) | -6.622 units on a scale | Standard Deviation 8.9353 |
| Placebo | Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score on Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 21 | Day 4 (n=26, 22, 46) | -3.761 units on a scale | Standard Deviation 9.682 |
| Placebo | Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score on Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 21 | Day 11 (n=21, 20, 46) | -6.924 units on a scale | Standard Deviation 10.4371 |
| Placebo | Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score on Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 21 | Day 8 (n=21, 19, 46) | -5.272 units on a scale | Standard Deviation 9.804 |
Comparison: Day 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.039280% CI: [1.3659, 5.6952]Mixed Models Analysis
Comparison: Day 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.000380% CI: [4.6177, 9.2512]Mixed Models Analysis
Comparison: Day 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.054780% CI: [1.4544, 7.1232]Mixed Models Analysis
Comparison: Day 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.017680% CI: [2.6655, 8.6943]Mixed Models Analysis
Comparison: Day 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.77580% CI: [-2.53, 3.9704]Mixed Models Analysis
Comparison: Day 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.987480% CI: [-3.521, 3.4357]Mixed Models Analysis
Comparison: Day 4: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.779980% CI: [-3.513, 2.2629]Mixed Models Analysis
Comparison: Day 4: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.188180% CI: [0.08338, 6.1438]Mixed Models Analysis
Comparison: Day 5: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.403280% CI: [-0.8944, 4.2094]Mixed Models Analysis
Comparison: Day 5: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.005980% CI: [3.2314, 8.6193]Mixed Models Analysis
Comparison: Day 6: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.606780% CI: [-1.643, 3.8273]Mixed Models Analysis
Comparison: Day 6: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.061480% CI: [1.3709, 7.186]Mixed Models Analysis
Comparison: Day 7: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.747680% CI: [-3.584, 2.1546]Mixed Models Analysis
Comparison: Day 7: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.586380% CI: [-4.499, 1.8284]Mixed Models Analysis
Comparison: Day 8: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.959180% CI: [-2.771, 2.5593]Mixed Models Analysis
Comparison: Day 8: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.844280% CI: [-3.294, 2.4238]Mixed Models Analysis
Comparison: Day 9: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.197780% CI: [0.01391, 5.3613]Mixed Models Analysis
Comparison: Day 9: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.423580% CI: [-1.108, 4.7375]Mixed Models Analysis
Comparison: Day 10: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.188280% CI: [0.07015, 5.2147]Mixed Models Analysis
Comparison: Day 10: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.555580% CI: [-1.44, 3.8615]Mixed Models Analysis
Comparison: Day 11: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.153380% CI: [0.33169, 6.0292]Mixed Models Analysis
Comparison: Day 11: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.369780% CI: [-0.8912, 4.9934]Mixed Models Analysis
Comparison: Day 12: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.465280% CI: [-1.352, 4.8801]Mixed Models Analysis
Comparison: Day 12: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.862680% CI: [-2.83, 3.7058]Mixed Models Analysis
Comparison: Day 13: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.026180% CI: [1.6105, 5.8122]Mixed Models Analysis
Comparison: Day 13: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.189580% CI: [0.0533, 4.4756]Mixed Models Analysis
Comparison: Day 14: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.499480% CI: [-1.961, 6.1913]Mixed Models Analysis
Comparison: Day 14: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.294580% CI: [-0.8226, 7.9458]Mixed Models Analysis
Comparison: Day 21: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.805680% CI: [-4.622, 3.1613]Mixed Models Analysis
Comparison: Day 21: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.392280% CI: [-1.725, 8.4592]Mixed Models Analysis
Secondary
Percentage of Participants With 1 or 2 Score on Clinical Global Impression-Severity Scale (CGI-S)
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Participants with a score of 1 (normal - not ill at all) or 2 (borderline mentally ill) are reported.
Time frame: Week 1, 2, 3
Population: PP analysis set:all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-03654746 (Low Dose) | Percentage of Participants With 1 or 2 Score on Clinical Global Impression-Severity Scale (CGI-S) | Week 2 (n=23, 20, 49) | 0.0 percentage of participants |
| PF-03654746 (Low Dose) | Percentage of Participants With 1 or 2 Score on Clinical Global Impression-Severity Scale (CGI-S) | Week 1 (n=26, 22, 50) | 3.846 percentage of participants |
| PF-03654746 (Low Dose) | Percentage of Participants With 1 or 2 Score on Clinical Global Impression-Severity Scale (CGI-S) | Week 3 (n=25, 21, 50) | 8 percentage of participants |
| PF-03654746 (Flexible Dose) | Percentage of Participants With 1 or 2 Score on Clinical Global Impression-Severity Scale (CGI-S) | Week 2 (n=23, 20, 49) | 5 percentage of participants |
| PF-03654746 (Flexible Dose) | Percentage of Participants With 1 or 2 Score on Clinical Global Impression-Severity Scale (CGI-S) | Week 1 (n=26, 22, 50) | 4.545 percentage of participants |
| PF-03654746 (Flexible Dose) | Percentage of Participants With 1 or 2 Score on Clinical Global Impression-Severity Scale (CGI-S) | Week 3 (n=25, 21, 50) | 4.762 percentage of participants |
| Placebo | Percentage of Participants With 1 or 2 Score on Clinical Global Impression-Severity Scale (CGI-S) | Week 1 (n=26, 22, 50) | 2 percentage of participants |
| Placebo | Percentage of Participants With 1 or 2 Score on Clinical Global Impression-Severity Scale (CGI-S) | Week 3 (n=25, 21, 50) | 6 percentage of participants |
| Placebo | Percentage of Participants With 1 or 2 Score on Clinical Global Impression-Severity Scale (CGI-S) | Week 2 (n=23, 20, 49) | 4.082 percentage of participants |
Secondary
Percentage of Participants With at Least 30 Percent Decrease From Baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) Total Score
AISRS: an 18-item scale administered by the investigator. It included 9 items that evaluated symptoms of inattention and 9 items that evaluated symptoms of impulsivity and hyperactivity. Each item was rated from 0 (none) to 3 (severe). AISRS total score was calculated as sum of all the items on the scale and ranged from 0 to 54. A higher score corresponded to a worse severity of ADHD.
Time frame: Week 1, 2, 3
Population: PP analysis set:all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-03654746 (Low Dose) | Percentage of Participants With at Least 30 Percent Decrease From Baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) Total Score | Week 2 (n=23, 20, 46) | 26.087 percentage of participants |
| PF-03654746 (Low Dose) | Percentage of Participants With at Least 30 Percent Decrease From Baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) Total Score | Week 1 (n=26, 22, 50) | 15.385 percentage of participants |
| PF-03654746 (Low Dose) | Percentage of Participants With at Least 30 Percent Decrease From Baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) Total Score | Week 3 (n=25, 21, 48) | 24 percentage of participants |
| PF-03654746 (Flexible Dose) | Percentage of Participants With at Least 30 Percent Decrease From Baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) Total Score | Week 2 (n=23, 20, 46) | 30 percentage of participants |
| PF-03654746 (Flexible Dose) | Percentage of Participants With at Least 30 Percent Decrease From Baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) Total Score | Week 1 (n=26, 22, 50) | 13.636 percentage of participants |
| PF-03654746 (Flexible Dose) | Percentage of Participants With at Least 30 Percent Decrease From Baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) Total Score | Week 3 (n=25, 21, 48) | 23.81 percentage of participants |
| Placebo | Percentage of Participants With at Least 30 Percent Decrease From Baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) Total Score | Week 1 (n=26, 22, 50) | 24 percentage of participants |
| Placebo | Percentage of Participants With at Least 30 Percent Decrease From Baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) Total Score | Week 3 (n=25, 21, 48) | 29.167 percentage of participants |
| Placebo | Percentage of Participants With at Least 30 Percent Decrease From Baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) Total Score | Week 2 (n=23, 20, 46) | 30.435 percentage of participants |
Secondary
Percentage of Participants With Less Than or Equal to 18 Score on Adult ADHD Investigator Symptom Rating Scale (AISRS)
AISRS: an 18-item scale administered by the investigator. It included 9 items that evaluated symptoms of inattention and 9 items that evaluated symptoms of impulsivity and hyperactivity. Each item was rated from 0 (none) to 3 (severe). AISRS total score was calculated as sum of all the items on the scale and ranged from 0 to 54. A higher score corresponded to a worse severity of ADHD.
Time frame: Week 1, 2, 3
Population: PP analysis set:all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-03654746 (Low Dose) | Percentage of Participants With Less Than or Equal to 18 Score on Adult ADHD Investigator Symptom Rating Scale (AISRS) | Week 1 (n=26, 22, 50) | 11.538 percentage of participants |
| PF-03654746 (Low Dose) | Percentage of Participants With Less Than or Equal to 18 Score on Adult ADHD Investigator Symptom Rating Scale (AISRS) | Week 2 (n=23, 20, 46) | 21.739 percentage of participants |
| PF-03654746 (Low Dose) | Percentage of Participants With Less Than or Equal to 18 Score on Adult ADHD Investigator Symptom Rating Scale (AISRS) | Week 3 (n=25, 21, 48) | 16 percentage of participants |
| PF-03654746 (Flexible Dose) | Percentage of Participants With Less Than or Equal to 18 Score on Adult ADHD Investigator Symptom Rating Scale (AISRS) | Week 3 (n=25, 21, 48) | 14.286 percentage of participants |
| PF-03654746 (Flexible Dose) | Percentage of Participants With Less Than or Equal to 18 Score on Adult ADHD Investigator Symptom Rating Scale (AISRS) | Week 2 (n=23, 20, 46) | 10 percentage of participants |
| PF-03654746 (Flexible Dose) | Percentage of Participants With Less Than or Equal to 18 Score on Adult ADHD Investigator Symptom Rating Scale (AISRS) | Week 1 (n=26, 22, 50) | 4.545 percentage of participants |
| Placebo | Percentage of Participants With Less Than or Equal to 18 Score on Adult ADHD Investigator Symptom Rating Scale (AISRS) | Week 1 (n=26, 22, 50) | 14 percentage of participants |
| Placebo | Percentage of Participants With Less Than or Equal to 18 Score on Adult ADHD Investigator Symptom Rating Scale (AISRS) | Week 3 (n=25, 21, 48) | 16.667 percentage of participants |
| Placebo | Percentage of Participants With Less Than or Equal to 18 Score on Adult ADHD Investigator Symptom Rating Scale (AISRS) | Week 2 (n=23, 20, 46) | 13.043 percentage of participants |
Secondary
Percentage of Participants With Sustained Response of at Least 30 Percent Decrease From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score
TASS: a time sensitive 18-item questionnaire completed by the participant that measured the severity of current ADHD symptoms. It included 9 items that evaluate symptoms of inattention sub-scale and 9 items that evaluate symptoms of impulsivity and hyperactivity sub-scale. Each item was rated from 0 (none) to 3 (severe). TASS total score was calculated as sum of all the items on the scale and ranged from 0 to 54. A higher total score corresponds to a worse severity of ADHD. TASS was administered each day from Day 1 to 14 and on Day 21 in each intervention period. Participants with sustained response were those who had at least 30 percent decrease from baseline in TASS total score, which was maintained at all visits up to the time of assessment. Sustained responders at Day 7, 14 and 21 were analyzed.
Time frame: Day 7, 14, 21
Population: PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-03654746 (Low Dose) | Percentage of Participants With Sustained Response of at Least 30 Percent Decrease From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score | Day 21 (n=9, 6, 22) | 33.333 percentage of participants |
| PF-03654746 (Low Dose) | Percentage of Participants With Sustained Response of at Least 30 Percent Decrease From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score | Day 7 (n=21, 18, 45) | 38.095 percentage of participants |
| PF-03654746 (Low Dose) | Percentage of Participants With Sustained Response of at Least 30 Percent Decrease From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score | Day 14 (n=17, 16, 35) | 23.529 percentage of participants |
| PF-03654746 (Flexible Dose) | Percentage of Participants With Sustained Response of at Least 30 Percent Decrease From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score | Day 21 (n=9, 6, 22) | 16.667 percentage of participants |
| PF-03654746 (Flexible Dose) | Percentage of Participants With Sustained Response of at Least 30 Percent Decrease From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score | Day 7 (n=21, 18, 45) | 27.778 percentage of participants |
| PF-03654746 (Flexible Dose) | Percentage of Participants With Sustained Response of at Least 30 Percent Decrease From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score | Day 14 (n=17, 16, 35) | 31.25 percentage of participants |
| Placebo | Percentage of Participants With Sustained Response of at Least 30 Percent Decrease From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score | Day 21 (n=9, 6, 22) | 40.909 percentage of participants |
| Placebo | Percentage of Participants With Sustained Response of at Least 30 Percent Decrease From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score | Day 7 (n=21, 18, 45) | 33.333 percentage of participants |
| Placebo | Percentage of Participants With Sustained Response of at Least 30 Percent Decrease From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score | Day 14 (n=17, 16, 35) | 31.429 percentage of participants |
Other Pre-specified
Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3
Participant-rated 12-item questionnaire to assess sleep quality and quantity. The items contribute to each scale and are averaged to create the 7 subscale scores: sleep disturbance, snoring, awaken short of breath (ASoB) or with a headache, somnolence, sleep adequacy, sleep quantity (range 0 to 24) and optimal sleep, and overall sleep problem index (SPI) I (range 0 to 600) and II. Except for sleep quantity and sleep problem index I, scores are transformed (actual raw score minus lowest possible score divided by possible raw score range\* 100); total score range: 0 to 100; higher score = greater intensity of attribute. Except for sleep quantity, higher scores=greater impairment. Scales with at least one item answered was used to generate a scale score.
Time frame: Baseline, Week 1, 2, 3
Population: PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here 'n' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-03654746 (Low Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Baseline: Snoring (n=26, 22, 51) | 43.462 units on a scale | Standard Deviation 29.1125 |
| PF-03654746 (Low Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 2: Sleep Adequacy (n=22, 20, 45) | 7.955 units on a scale | Standard Deviation 17.6378 |
| PF-03654746 (Low Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 2: Snoring (n=22, 19, 45) | -12.273 units on a scale | Standard Deviation 17.1636 |
| PF-03654746 (Low Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Baseline: ASoB (n=27, 22, 52) | 3.333 units on a scale | Standard Deviation 8.7706 |
| PF-03654746 (Low Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 3: Sleep quantity (n=24, 20, 47) | -0.354 units on a scale | Standard Deviation 0.8658 |
| PF-03654746 (Low Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 2: Sleep disturbance (n=23, 20, 46) | 3.904 units on a scale | Standard Deviation 18.0117 |
| PF-03654746 (Low Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 1: SPI II (n=26, 22, 50) | 7.65 units on a scale | Standard Deviation 16.0588 |
| PF-03654746 (Low Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Baseline: Sleep adequacy (n=26, 22, 51) | 40.962 units on a scale | Standard Deviation 22.8044 |
| PF-03654746 (Low Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Baseline: Sleep quantity (n=27, 22, 52) | 6.537 units on a scale | Standard Deviation 0.95 |
| PF-03654746 (Low Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 1: Somnolence (n=25, 22, 49) | -8.267 units on a scale | Standard Deviation 21.7545 |
| PF-03654746 (Low Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Baseline: Somnolence (n=26, 22, 51) | 31.795 units on a scale | Standard Deviation 19.6238 |
| PF-03654746 (Low Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 1: SPI I (n=25, 22, 49) | 35.2 units on a scale | Standard Deviation 81.7068 |
| PF-03654746 (Low Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 1: Sleep Adequacy (n=25, 22, 49) | -1.8 units on a scale | Standard Deviation 15.6045 |
| PF-03654746 (Low Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Baseline: SPI I (n=26, 22, 51) | 201.538 units on a scale | Standard Deviation 69.0329 |
| PF-03654746 (Low Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 3: Snoring (n=24, 20, 44) | -7.917 units on a scale | Standard Deviation 14.44 |
| PF-03654746 (Low Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Baseline: SPI II (n=27, 22, 52) | 33.251 units on a scale | Standard Deviation 12.8016 |
| PF-03654746 (Low Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 3: ASoB (n=25, 21, 47) | -0.4 units on a scale | Standard Deviation 12.0692 |
| PF-03654746 (Low Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 1: Sleep disturbance (n=26, 22, 50) | 18.245 units on a scale | Standard Deviation 30.9066 |
| PF-03654746 (Low Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Baseline: Optimal sleep (n=27, 22, 52) | 1.593 units on a scale | Standard Deviation 0.4169 |
| PF-03654746 (Low Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 1: Optimal sleep (n=26, 22, 50) | 0 units on a scale | Standard Deviation 0.4899 |
| PF-03654746 (Low Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 1: Snoring (n=25, 21, 48) | -14.8 units on a scale | Standard Deviation 19.1746 |
| PF-03654746 (Low Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 2: SPI II (n=23, 20, 46) | -0.242 units on a scale | Standard Deviation 11.7718 |
| PF-03654746 (Low Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 1: Sleep quantity (n=25, 22, 48) | -0.42 units on a scale | Standard Deviation 1.3204 |
| PF-03654746 (Low Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 1: ASoB (n=26, 22, 50) | 4.231 units on a scale | Standard Deviation 15.7919 |
| PF-03654746 (Low Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 3: Optimal sleep (n=25, 21, 50) | 0.08 units on a scale | Standard Deviation 0.4491 |
| PF-03654746 (Low Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 2: ASoB (n=23, 20, 46) | 0.435 units on a scale | Standard Deviation 11.0693 |
| PF-03654746 (Low Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 3: SPI II (n=25, 21, 47) | -2.511 units on a scale | Standard Deviation 14.1763 |
| PF-03654746 (Low Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 2: SPI I (n=22, 20, 45) | -15.455 units on a scale | Standard Deviation 71.6956 |
| PF-03654746 (Low Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 3: Somnolence (n=24, 21, 45) | -8.889 units on a scale | Standard Deviation 19.5274 |
| PF-03654746 (Low Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 2: Optimal sleep (n=23, 20, 49) | 0.065 units on a scale | Standard Deviation 0.4074 |
| PF-03654746 (Low Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 2: Somnolence (n=22, 20, 45) | -6.061 units on a scale | Standard Deviation 16.9542 |
| PF-03654746 (Low Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 3: SPI I (n=24, 21, 45) | -20.833 units on a scale | Standard Deviation 71.7433 |
| PF-03654746 (Low Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 3: Sleep Adequacy (n=24, 21, 45) | 3.958 units on a scale | Standard Deviation 19.1663 |
| PF-03654746 (Low Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Baseline: Sleep disturbance (n=27, 22, 52) | 27.894 units on a scale | Standard Deviation 19.427 |
| PF-03654746 (Low Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 3: Sleep disturbance (n=25, 21, 47) | -0.875 units on a scale | Standard Deviation 18.0287 |
| PF-03654746 (Low Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 2: Sleep quantity (22, 20, 46) | -0.182 units on a scale | Standard Deviation 0.958 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 3: Sleep Adequacy (n=24, 21, 45) | -2.381 units on a scale | Standard Deviation 25.5254 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Baseline: Optimal sleep (n=27, 22, 52) | 1.5 units on a scale | Standard Deviation 0.4082 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 1: ASoB (n=26, 22, 50) | -2.273 units on a scale | Standard Deviation 9.2231 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 2: Sleep disturbance (n=23, 20, 46) | 0.438 units on a scale | Standard Deviation 27.3712 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 2: ASoB (n=23, 20, 46) | 1.5 units on a scale | Standard Deviation 14.2441 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 2: Optimal sleep (n=23, 20, 49) | -0.1 units on a scale | Standard Deviation 0.4472 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 2: Sleep Adequacy (n=22, 20, 45) | 4.5 units on a scale | Standard Deviation 23.6699 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 2: Somnolence (n=22, 20, 45) | -4.333 units on a scale | Standard Deviation 14.3515 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 2: SPI I (n=22, 20, 45) | 1.5 units on a scale | Standard Deviation 103.937 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 3: Snoring (n=24, 20, 44) | -5.5 units on a scale | Standard Deviation 20.1246 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 3: ASoB (n=25, 21, 47) | 6.19 units on a scale | Standard Deviation 19.3588 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 3: Optimal sleep (n=25, 21, 50) | 0 units on a scale | Standard Deviation 0.5477 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Baseline: ASoB (n=27, 22, 52) | 7.727 units on a scale | Standard Deviation 17.7098 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 3: Somnolence (n=24, 21, 45) | 0.635 units on a scale | Standard Deviation 13.3591 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 3: SPI I (n=24, 21, 45) | 31.905 units on a scale | Standard Deviation 108.3337 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Baseline: Sleep disturbance (n=27, 22, 52) | 34.489 units on a scale | Standard Deviation 20.6801 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Baseline: Snoring (n=26, 22, 51) | 44.091 units on a scale | Standard Deviation 32.9009 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Baseline: Sleep quantity (n=27, 22, 52) | 6.705 units on a scale | Standard Deviation 0.9594 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Baseline: Sleep adequacy (n=26, 22, 51) | 41.364 units on a scale | Standard Deviation 26.1944 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Baseline: Somnolence (n=26, 22, 51) | 32.727 units on a scale | Standard Deviation 19.5893 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Baseline: SPI I (n=26, 22, 51) | 214.091 units on a scale | Standard Deviation 109.1377 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Baseline: SPI II (n=27, 22, 52) | 37.519 units on a scale | Standard Deviation 18.3575 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 1: Sleep disturbance (n=26, 22, 50) | 4.489 units on a scale | Standard Deviation 23.7105 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 1: Snoring (n=25, 21, 48) | -4.286 units on a scale | Standard Deviation 17.7684 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 1: Sleep quantity (n=25, 22, 48) | -0.114 units on a scale | Standard Deviation 0.8442 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 1: Optimal sleep (n=26, 22, 50) | 0 units on a scale | Standard Deviation 0.5345 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 1: Sleep Adequacy (n=25, 22, 49) | -6.818 units on a scale | Standard Deviation 27.1041 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 1: Somnolence (n=25, 22, 49) | -1.818 units on a scale | Standard Deviation 13.8674 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 1: SPI I (n=25, 22, 49) | 25 units on a scale | Standard Deviation 105.9088 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 1: SPI II (n=26, 22, 50) | 2.936 units on a scale | Standard Deviation 17.1929 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 2: Snoring (n=22, 19, 45) | -17.368 units on a scale | Standard Deviation 14.4692 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 2: Sleep quantity (22, 20, 46) | 0.025 units on a scale | Standard Deviation 0.8955 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 2: SPI II (n=23, 20, 46) | -1.438 units on a scale | Standard Deviation 17.3576 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 3: Sleep disturbance (n=25, 21, 47) | 6.31 units on a scale | Standard Deviation 24.7652 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 3: Sleep quantity (n=24, 20, 47) | -0.025 units on a scale | Standard Deviation 0.9244 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 3: SPI II (n=25, 21, 47) | 4.636 units on a scale | Standard Deviation 18.1315 |
| Placebo | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 1: Somnolence (n=25, 22, 49) | -1.769 units on a scale | Standard Deviation 16.4444 |
| Placebo | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Baseline: SPI II (n=27, 22, 52) | 34.848 units on a scale | Standard Deviation 15.5578 |
| Placebo | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 1: SPI I (n=25, 22, 49) | -21.224 units on a scale | Standard Deviation 85.9901 |
| Placebo | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Baseline: Optimal sleep (n=27, 22, 52) | 1.558 units on a scale | Standard Deviation 0.416 |
| Placebo | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 3: SPI II (n=25, 21, 47) | -6.238 units on a scale | Standard Deviation 12.4191 |
| Placebo | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Baseline: Sleep quantity (n=27, 22, 52) | 6.673 units on a scale | Standard Deviation 1.0379 |
| Placebo | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 2: Sleep disturbance (n=23, 20, 46) | -11.984 units on a scale | Standard Deviation 15.9101 |
| Placebo | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Baseline: Snoring (n=26, 22, 51) | 40.784 units on a scale | Standard Deviation 29.9895 |
| Placebo | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 3: Optimal sleep (n=25, 21, 50) | -0.12 units on a scale | Standard Deviation 0.5206 |
| Placebo | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 2: Snoring (n=22, 19, 45) | -12 units on a scale | Standard Deviation 14.554 |
| Placebo | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 2: ASoB (n=23, 20, 46) | -3.478 units on a scale | Standard Deviation 11.1987 |
| Placebo | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Baseline: Sleep disturbance (n=27, 22, 52) | 29.892 units on a scale | Standard Deviation 20.4408 |
| Placebo | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Baseline: SPI I (n=26, 22, 51) | 210.196 units on a scale | Standard Deviation 87.7836 |
| Placebo | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 2: Sleep quantity (22, 20, 46) | 0.152 units on a scale | Standard Deviation 0.9121 |
| Placebo | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 2: Sleep Adequacy (n=22, 20, 45) | 6.111 units on a scale | Standard Deviation 24.0711 |
| Placebo | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 3: Somnolence (n=24, 21, 45) | -1.704 units on a scale | Standard Deviation 12.4848 |
| Placebo | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 2: Somnolence (n=22, 20, 45) | -5.333 units on a scale | Standard Deviation 14.6059 |
| Placebo | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 3: Sleep Adequacy (n=24, 21, 45) | 3 units on a scale | Standard Deviation 17.235 |
| Placebo | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 2: SPI I (n=22, 20, 45) | -45.333 units on a scale | Standard Deviation 74.8817 |
| Placebo | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 3: Sleep quantity (n=24, 20, 47) | 0.16 units on a scale | Standard Deviation 1.0638 |
| Placebo | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 3: SPI I (n=24, 21, 45) | -25.778 units on a scale | Standard Deviation 71.6205 |
| Placebo | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 2: SPI II (n=23, 20, 46) | -8.155 units on a scale | Standard Deviation 12.6707 |
| Placebo | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 2: Optimal sleep (n=23, 20, 49) | -0.122 units on a scale | Standard Deviation 0.4845 |
| Placebo | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Baseline: ASoB (n=27, 22, 52) | 6.154 units on a scale | Standard Deviation 14.1635 |
| Placebo | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 1: ASoB (n=26, 22, 50) | -1.6 units on a scale | Standard Deviation 14.3371 |
| Placebo | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 1: Snoring (n=25, 21, 48) | -10.417 units on a scale | Standard Deviation 14.1359 |
| Placebo | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 3: Sleep disturbance (n=25, 21, 47) | -12.114 units on a scale | Standard Deviation 15.1541 |
| Placebo | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 1: Sleep quantity (n=25, 22, 48) | 0.198 units on a scale | Standard Deviation 1.0249 |
| Placebo | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 1: Sleep disturbance (n=26, 22, 50) | -8.263 units on a scale | Standard Deviation 18.8354 |
| Placebo | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 3: Snoring (n=24, 20, 44) | -6.364 units on a scale | Standard Deviation 13.6554 |
| Placebo | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 1: Optimal sleep (n=26, 22, 50) | -0.14 units on a scale | Standard Deviation 0.5349 |
| Placebo | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Baseline: Somnolence (n=26, 22, 51) | 30.85 units on a scale | Standard Deviation 20.2522 |
| Placebo | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 1: SPI II (n=26, 22, 50) | -3.875 units on a scale | Standard Deviation 14.2472 |
| Placebo | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 1: Sleep Adequacy (n=25, 22, 49) | -0.408 units on a scale | Standard Deviation 21.5985 |
| Placebo | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Baseline: Sleep adequacy (n=26, 22, 51) | 39.804 units on a scale | Standard Deviation 23.4512 |
| Placebo | Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3 | Change at Week 3: ASoB (n=25, 21, 47) | 1.702 units on a scale | Standard Deviation 22.4886 |
Comparison: Week 1 (Sleep disturbance): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: <0.000180% CI: [18.565, 31.591]Mixed Models Analysis
Comparison: Week 1 (Sleep disturbance): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.004980% CI: [8.711, 22.585]Mixed Models Analysis
Comparison: Week 1 (Snoring): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.307880% CI: [-8.196, 0.94237]Mixed Models Analysis
Comparison: Week 1 (Snoring): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.064480% CI: [2.2344, 12.084]Mixed Models Analysis
Comparison: Week 1 (ASoB): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.151780% CI: [0.49198, 8.6281]Mixed Models Analysis
Comparison: Week 1 (ASoB): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.825280% CI: [-5.056, 3.5789]Mixed Models Analysis
Comparison: Week 1 (Sleep quantity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.006380% CI: [-0.9082, -0.3375]Mixed Models Analysis
Comparison: Week 1 (Sleep quantity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.321780% CI: [-0.5283, 0.06822]Mixed Models Analysis
Comparison: Week 1 (Optimal sleep): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.230780% CI: [-0.0091, 0.26716]Mixed Models Analysis
Comparison: Week 1 (Optimal sleep): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.458580% CI: [-0.0598, 0.22209]Mixed Models Analysis
Comparison: Week 1 (Sleep adequacy): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.347780% CI: [-8.681, 1.3549]Mixed Models Analysis
Comparison: Week 1 (Sleep adequacy): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.156580% CI: [-11.17, -0.5693]Mixed Models Analysis
Comparison: Week 1 (Somnolence): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.108880% CI: [-11.55, -1.311]Mixed Models Analysis
Comparison: Week 1 (Somnolence): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.862780% CI: [-4.654, 6.0952]Mixed Models Analysis
Comparison: Week 1 (SPI I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.002480% CI: [33.532, 79.73]Mixed Models Analysis
Comparison: Week 1 (SPI I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.011280% CI: [24.831, 73.478]Mixed Models Analysis
Comparison: Week 1 (SPI II): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.000880% CI: [6.9105, 14.929]Mixed Models Analysis
Comparison: Week 1 (SPI II): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.012980% CI: [4.1876, 12.751]Mixed Models Analysis
Comparison: Week 2 (Sleep disturbance): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.00280% CI: [8.4492, 19.766]Mixed Models Analysis
Comparison: Week 2 (Sleep disturbance): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.002680% CI: [8.4275, 20.27]Mixed Models Analysis
Comparison: Week 2 (Snoring): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.930580% CI: [-4.729, 4.1309]Mixed Models Analysis
Comparison: Week 2 (Snoring): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.117880% CI: [-10.36, -1.05]Mixed Models Analysis
Comparison: Week 2 (ASoB): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.333980% CI: [-0.8124, 5.7295]Mixed Models Analysis
Comparison: Week 2 (ASoB): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.069880% CI: [1.4493, 8.2686]Mixed Models Analysis
Comparison: Week 2 (Sleep quantity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.076280% CI: [-0.5777, -0.095]Mixed Models Analysis
Comparison: Week 2 (Sleep quantity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.409680% CI: [-0.4075, 0.08935]Mixed Models Analysis
Comparison: Week 2 (Optimal sleep): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.045580% CI: [0.07751, 0.3455]Mixed Models Analysis
Comparison: Week 2 (Optimal sleep): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.458580% CI: [-0.0598, 0.22209]Mixed Models Analysis
Comparison: Week 2 (Sleep adequacy): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.907880% CI: [-5.513, 6.5995]Mixed Models Analysis
Comparison: Week 2 (Sleep adequacy): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.650280% CI: [-8.403, 4.0338]Mixed Models Analysis
Comparison: Week 2 (Somnolence): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.80980% CI: [-5.716, 3.9101]Mixed Models Analysis
Comparison: Week 2 (Somnolence): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.528280% CI: [-2.532, 7.4025]Mixed Models Analysis
Comparison: Week 2 (SPI I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.184880% CI: [0.86393, 49.782]Mixed Models Analysis
Comparison: Week 2 (SPI I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.012480% CI: [25.134, 75.677]Mixed Models Analysis
Comparison: Week 2 (SPI II): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.026780% CI: [2.9504, 10.781]Mixed Models Analysis
Comparison: Week 2 (SPI II): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.013480% CI: [3.9787, 12.192]Mixed Models Analysis
Comparison: Week 3 (Sleep disturbance): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.015280% CI: [4.5949, 14.453]Mixed Models Analysis
Comparison: Week 3 (Sleep disturbance): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: <0.000180% CI: [14.602, 25.359]Mixed Models Analysis
Comparison: Week 3 (Snoring): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.351680% CI: [-6.59, 1.0562]Mixed Models Analysis
Comparison: Week 3 (Snoring): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.344880% CI: [-1.116, 7.2838]Mixed Models Analysis
Comparison: Week 3 (ASoB): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.558380% CI: [-8.294, 3.1175]Mixed Models Analysis
Comparison: Week 3 (ASoB): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.114180% CI: [1.4717, 13.838]Mixed Models Analysis
Comparison: Week 3 (Sleep quantity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.003480% CI: [-0.8356, -0.3408]Mixed Models Analysis
Comparison: Week 3 (Sleep quantity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.408380% CI: [-0.4403, 0.09599]Mixed Models Analysis
Comparison: Week 3 (Optimal sleep): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.01280% CI: [0.13746, 0.41127]Mixed Models Analysis
Comparison: Week 3 (Optimal sleep): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.37580% CI: [-0.0457, 0.24881]Mixed Models Analysis
Comparison: Week 3 (Sleep adequacy): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.911980% CI: [-4.665, 5.5387]Mixed Models Analysis
Comparison: Week 3 (Sleep adequacy): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.136780% CI: [-11.79, -0.896]Mixed Models Analysis
Comparison: Week 3 (Somnolence): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.059580% CI: [-10.05, -1.964]Mixed Models Analysis
Comparison: Week 3 (Somnolence): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.135680% CI: [0.72505, 9.3473]Mixed Models Analysis
Comparison: Week 3 (SPI I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.752880% CI: [-15.99, 26.303]Mixed Models Analysis
Comparison: Week 3 (SPI I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.000380% CI: [45.114, 90.29]Mixed Models Analysis
Comparison: Week 3 (SPI II): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.283780% CI: [-0.567, 6.2835]Mixed Models Analysis
Comparison: Week 3 (SPI II): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: <0.000180% CI: [9.1761, 16.674]Mixed Models Analysis
Other Pre-specified
Change From Baseline in Subjective Sleep Questionnaire (SSQ) Hours of Sleep Subscale Scores at Week 1, 2 and 3
SSQ is a 5-item self-report scale that was designed to evaluate the amount and quality of sleep and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), WASO (1 item), quality of sleep (1 item). Hours of sleep subscale score ranges from 0-16 hours. Higher value indicates better sleep.
Time frame: Baseline, Week 1, 2, 3
Population: PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here 'n' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-03654746 (Low Dose) | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Hours of Sleep Subscale Scores at Week 1, 2 and 3 | Baseline (n=27, 22, 52) | 6.05 hours | Standard Deviation 1.0963 |
| PF-03654746 (Low Dose) | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Hours of Sleep Subscale Scores at Week 1, 2 and 3 | Change at Week 3 (n=18, 11, 36) | -0.148 hours | Standard Deviation 1.7562 |
| PF-03654746 (Low Dose) | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Hours of Sleep Subscale Scores at Week 1, 2 and 3 | Change at Week 1 (n=25, 22, 43) | 0.147 hours | Standard Deviation 1.4865 |
| PF-03654746 (Low Dose) | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Hours of Sleep Subscale Scores at Week 1, 2 and 3 | Change at Week 2 (21, 19, 43) | 0.414 hours | Standard Deviation 1.2911 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Hours of Sleep Subscale Scores at Week 1, 2 and 3 | Change at Week 1 (n=25, 22, 43) | 0.414 hours | Standard Deviation 2.0816 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Hours of Sleep Subscale Scores at Week 1, 2 and 3 | Change at Week 2 (21, 19, 43) | 0.319 hours | Standard Deviation 1.7 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Hours of Sleep Subscale Scores at Week 1, 2 and 3 | Change at Week 3 (n=18, 11, 36) | -0.17 hours | Standard Deviation 2.0091 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Hours of Sleep Subscale Scores at Week 1, 2 and 3 | Baseline (n=27, 22, 52) | 6.48 hours | Standard Deviation 1.2806 |
| Placebo | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Hours of Sleep Subscale Scores at Week 1, 2 and 3 | Change at Week 1 (n=25, 22, 43) | 0.763 hours | Standard Deviation 1.5914 |
| Placebo | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Hours of Sleep Subscale Scores at Week 1, 2 and 3 | Change at Week 2 (21, 19, 43) | 0.865 hours | Standard Deviation 1.4959 |
| Placebo | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Hours of Sleep Subscale Scores at Week 1, 2 and 3 | Baseline (n=27, 22, 52) | 6.364 hours | Standard Deviation 1.2534 |
| Placebo | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Hours of Sleep Subscale Scores at Week 1, 2 and 3 | Change at Week 3 (n=18, 11, 36) | 0.717 hours | Standard Deviation 1.2305 |
Comparison: Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.000380% CI: [-0.9046, -0.4487]Mixed Models Analysis
Comparison: Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.105580% CI: [-0.5499, -0.065]Mixed Models Analysis
Comparison: Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.011980% CI: [-0.7012, -0.2356]Mixed Models Analysis
Comparison: Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.501680% CI: [-0.3687, 0.11608]Mixed Models Analysis
Comparison: Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.053180% CI: [-0.5711, -0.1191]Mixed Models Analysis
Comparison: Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.030680% CI: [-0.6549, -0.1725]Mixed Models Analysis
Other Pre-specified
Change From Baseline in Subjective Sleep Questionnaire (SSQ) Latency Subscale Scores at Week 1, 2 and 3
SSQ is a 5-item self-report scale that was designed to evaluate the amount and quality of sleep and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total awake after sleep onset (WASO \[1 item\]), quality of sleep (1 item). Latency subscale score ranges from 0-840 minutes. Lower value indicates better sleep.
Time frame: Baseline, Week 1, 2, 3
Population: PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here 'n' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-03654746 (Low Dose) | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Latency Subscale Scores at Week 1, 2 and 3 | Change at Week 3 (n=18, 11, 36) | -3.222 minutes | Standard Deviation 36.2086 |
| PF-03654746 (Low Dose) | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Latency Subscale Scores at Week 1, 2 and 3 | Baseline (n=27, 22, 52) | 30.333 minutes | Standard Deviation 35.7464 |
| PF-03654746 (Low Dose) | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Latency Subscale Scores at Week 1, 2 and 3 | Change at Week 1 (n=25, 22, 43) | 24.6 minutes | Standard Deviation 89.6858 |
| PF-03654746 (Low Dose) | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Latency Subscale Scores at Week 1, 2 and 3 | Change at Week 2 (n=21, 19, 43) | -3.024 minutes | Standard Deviation 23.4763 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Latency Subscale Scores at Week 1, 2 and 3 | Baseline (n=27, 22, 52) | 31.364 minutes | Standard Deviation 29.7582 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Latency Subscale Scores at Week 1, 2 and 3 | Change at Week 3 (n=18, 11, 36) | 4.091 minutes | Standard Deviation 66.954 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Latency Subscale Scores at Week 1, 2 and 3 | Change at Week 2 (n=21, 19, 43) | -12.632 minutes | Standard Deviation 31.1858 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Latency Subscale Scores at Week 1, 2 and 3 | Change at Week 1 (n=25, 22, 43) | -3.409 minutes | Standard Deviation 46.2302 |
| Placebo | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Latency Subscale Scores at Week 1, 2 and 3 | Change at Week 3 (n=18, 11, 36) | -11.958 minutes | Standard Deviation 30.2856 |
| Placebo | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Latency Subscale Scores at Week 1, 2 and 3 | Change at Week 1 (n=25, 22, 43) | 0.837 minutes | Standard Deviation 60.9442 |
| Placebo | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Latency Subscale Scores at Week 1, 2 and 3 | Change at Week 2 (n=21, 19, 43) | -11.105 minutes | Standard Deviation 23.2396 |
| Placebo | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Latency Subscale Scores at Week 1, 2 and 3 | Baseline (n=27, 22, 52) | 29.067 minutes | Standard Deviation 31.8087 |
Comparison: Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: <0.000180% CI: [21.777, 31.946]Mixed Models Analysis
Comparison: Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.303480% CI: [-1.08, 9.7713]Mixed Models Analysis
Comparison: Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.022380% CI: [3.132, 10.78]Mixed Models Analysis
Comparison: Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.228480% CI: [-0.2442, 7.7479]Mixed Models Analysis
Comparison: Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.020180% CI: [3.9265, 13.224]Mixed Models Analysis
Comparison: Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.193180% CI: [0.07753, 9.9683]Mixed Models Analysis
Other Pre-specified
Change From Baseline in Subjective Sleep Questionnaire (SSQ) Number of Awakenings Subscale Scores at Week 1, 2 and 3
SSQ is a 5-item self-report scale that was designed to evaluate the amount and quality of sleep and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), WASO (1 item), quality of sleep (1 item). Number of awakenings subscale score ranges from 0 to 30. Lower value indicates better sleep.
Time frame: Baseline, Week 1, 2, 3
Population: PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here 'n' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-03654746 (Low Dose) | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Number of Awakenings Subscale Scores at Week 1, 2 and 3 | Change at Week 2 (n=21, 19, 43) | -0.333 awakenings | Standard Deviation 1.977 |
| PF-03654746 (Low Dose) | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Number of Awakenings Subscale Scores at Week 1, 2 and 3 | Baseline (n=27, 22, 52) | 1.37 awakenings | Standard Deviation 1.4317 |
| PF-03654746 (Low Dose) | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Number of Awakenings Subscale Scores at Week 1, 2 and 3 | Change at Week 3 (n=18, 11, 36) | 0.028 awakenings | Standard Deviation 2.0398 |
| PF-03654746 (Low Dose) | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Number of Awakenings Subscale Scores at Week 1, 2 and 3 | Change at Week 1 (n=25, 22, 43) | 0.12 awakenings | Standard Deviation 1.6788 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Number of Awakenings Subscale Scores at Week 1, 2 and 3 | Change at Week 2 (n=21, 19, 43) | 0.158 awakenings | Standard Deviation 1.2589 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Number of Awakenings Subscale Scores at Week 1, 2 and 3 | Change at Week 1 (n=25, 22, 43) | 0.5 awakenings | Standard Deviation 1.7252 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Number of Awakenings Subscale Scores at Week 1, 2 and 3 | Baseline (n=27, 22, 52) | 1.182 awakenings | Standard Deviation 1.0065 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Number of Awakenings Subscale Scores at Week 1, 2 and 3 | Change at Week 3 (n=18, 11, 36) | 0.045 awakenings | Standard Deviation 1.4222 |
| Placebo | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Number of Awakenings Subscale Scores at Week 1, 2 and 3 | Change at Week 1 (n=25, 22, 43) | -0.209 awakenings | Standard Deviation 1.4402 |
| Placebo | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Number of Awakenings Subscale Scores at Week 1, 2 and 3 | Baseline (n=27, 22, 52) | 1.298 awakenings | Standard Deviation 1.2258 |
| Placebo | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Number of Awakenings Subscale Scores at Week 1, 2 and 3 | Change at Week 3 (n=18, 11, 36) | -0.361 awakenings | Standard Deviation 1.2627 |
| Placebo | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Number of Awakenings Subscale Scores at Week 1, 2 and 3 | Change at Week 2 (n=21, 19, 43) | -0.419 awakenings | Standard Deviation 1.2293 |
Comparison: Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: <0.000180% CI: [0.5426, 0.99157]Mixed Models Analysis
Comparison: Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.005980% CI: [0.28911, 0.76798]Mixed Models Analysis
Comparison: Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.292180% CI: [-0.0336, 0.33878]Mixed Models Analysis
Comparison: Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.192980% CI: [0.00319, 0.39272]Mixed Models Analysis
Comparison: Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.033280% CI: [0.13988, 0.54663]Mixed Models Analysis
Comparison: Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.016280% CI: [0.20006, 0.63674]Mixed Models Analysis
Other Pre-specified
Change From Baseline in Subjective Sleep Questionnaire (SSQ) Quality of Sleep Subscale Scores at Week 1, 2 and 3
SSQ is a 5-item self-report scale that was designed to evaluate the amount and quality of sleep and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), WASO (1 item), quality of sleep (1 item). Quality of sleep subscale score ranges from 0-100. Higher score indicates better quality of sleep.
Time frame: Baseline, Week 1, 2, 3
Population: PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here 'n' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-03654746 (Low Dose) | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Quality of Sleep Subscale Scores at Week 1, 2 and 3 | Change at Week 2 (n=21, 19, 43) | 8.286 units on a scale | Standard Deviation 22.3375 |
| PF-03654746 (Low Dose) | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Quality of Sleep Subscale Scores at Week 1, 2 and 3 | Change at Week 3 (n=18, 11, 36) | 7.222 units on a scale | Standard Deviation 21.7764 |
| PF-03654746 (Low Dose) | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Quality of Sleep Subscale Scores at Week 1, 2 and 3 | Baseline (n=27, 22, 52) | 57.093 units on a scale | Standard Deviation 19.7582 |
| PF-03654746 (Low Dose) | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Quality of Sleep Subscale Scores at Week 1, 2 and 3 | Change at Week 1 (n=25, 22, 42) | -4.06 units on a scale | Standard Deviation 21.0616 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Quality of Sleep Subscale Scores at Week 1, 2 and 3 | Change at Week 1 (n=25, 22, 42) | 0.5 units on a scale | Standard Deviation 25.6715 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Quality of Sleep Subscale Scores at Week 1, 2 and 3 | Change at Week 2 (n=21, 19, 43) | 11.105 units on a scale | Standard Deviation 22.6124 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Quality of Sleep Subscale Scores at Week 1, 2 and 3 | Baseline (n=27, 22, 52) | 55 units on a scale | Standard Deviation 23.4663 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Quality of Sleep Subscale Scores at Week 1, 2 and 3 | Change at Week 3 (n=18, 11, 36) | 0.182 units on a scale | Standard Deviation 44.302 |
| Placebo | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Quality of Sleep Subscale Scores at Week 1, 2 and 3 | Change at Week 1 (n=25, 22, 42) | 8.393 units on a scale | Standard Deviation 25.5447 |
| Placebo | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Quality of Sleep Subscale Scores at Week 1, 2 and 3 | Change at Week 3 (n=18, 11, 36) | 10.389 units on a scale | Standard Deviation 22.8602 |
| Placebo | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Quality of Sleep Subscale Scores at Week 1, 2 and 3 | Baseline (n=27, 22, 52) | 56.202 units on a scale | Standard Deviation 20.9533 |
| Placebo | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Quality of Sleep Subscale Scores at Week 1, 2 and 3 | Change at Week 2 (n=21, 19, 43) | 9.43 units on a scale | Standard Deviation 20.5434 |
Comparison: Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: <0.000180% CI: [-16.83, -9.828]Mixed Models Analysis
Comparison: Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.006880% CI: [-11.87, -4.382]Mixed Models Analysis
Comparison: Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.134680% CI: [-6.551, -0.5175]Mixed Models Analysis
Comparison: Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.655280% CI: [-2.067, 4.2494]Mixed Models Analysis
Comparison: Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.076580% CI: [-5.494, -0.9063]Mixed Models Analysis
Comparison: Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.047380% CI: [-6.349, -1.407]Mixed Models Analysis
Other Pre-specified
Change From Baseline in Subjective Sleep Questionnaire (SSQ) Total Awake After Sleep Onset (WASO) Subscale Scores at Week 1, 2 and 3
SSQ is a 5-item self-report scale that was designed to evaluate the amount and quality of sleep and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), WASO (1 item), quality of sleep (1 item). Total WASO subscale score ranges from 0 to 24 hours. Lower value indicates better sleep.
Time frame: Baseline, Week 1, 2, 3
Population: PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here 'n' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-03654746 (Low Dose) | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Total Awake After Sleep Onset (WASO) Subscale Scores at Week 1, 2 and 3 | Baseline (n=27, 22, 52) | 0.432 hours | Standard Deviation 0.6295 |
| PF-03654746 (Low Dose) | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Total Awake After Sleep Onset (WASO) Subscale Scores at Week 1, 2 and 3 | Change at Week 1 (25, 22, 43) | 0.109 hours | Standard Deviation 0.5542 |
| PF-03654746 (Low Dose) | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Total Awake After Sleep Onset (WASO) Subscale Scores at Week 1, 2 and 3 | Change at Week 2 (n=21, 19, 43) | -0.133 hours | Standard Deviation 0.7064 |
| PF-03654746 (Low Dose) | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Total Awake After Sleep Onset (WASO) Subscale Scores at Week 1, 2 and 3 | Change at Week 3 (n=18, 11, 36) | 0.091 hours | Standard Deviation 0.6291 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Total Awake After Sleep Onset (WASO) Subscale Scores at Week 1, 2 and 3 | Change at Week 3 (n=18, 11, 36) | 0.329 hours | Standard Deviation 1.3329 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Total Awake After Sleep Onset (WASO) Subscale Scores at Week 1, 2 and 3 | Baseline (n=27, 22, 52) | 0.578 hours | Standard Deviation 0.8214 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Total Awake After Sleep Onset (WASO) Subscale Scores at Week 1, 2 and 3 | Change at Week 2 (n=21, 19, 43) | -0.167 hours | Standard Deviation 0.8035 |
| PF-03654746 (Flexible Dose) | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Total Awake After Sleep Onset (WASO) Subscale Scores at Week 1, 2 and 3 | Change at Week 1 (25, 22, 43) | 0.013 hours | Standard Deviation 1.2797 |
| Placebo | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Total Awake After Sleep Onset (WASO) Subscale Scores at Week 1, 2 and 3 | Change at Week 2 (n=21, 19, 43) | -0.228 hours | Standard Deviation 0.8409 |
| Placebo | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Total Awake After Sleep Onset (WASO) Subscale Scores at Week 1, 2 and 3 | Change at Week 1 (25, 22, 43) | -0.286 hours | Standard Deviation 0.7444 |
| Placebo | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Total Awake After Sleep Onset (WASO) Subscale Scores at Week 1, 2 and 3 | Change at Week 3 (n=18, 11, 36) | -0.313 hours | Standard Deviation 0.6863 |
| Placebo | Change From Baseline in Subjective Sleep Questionnaire (SSQ) Total Awake After Sleep Onset (WASO) Subscale Scores at Week 1, 2 and 3 | Baseline (n=27, 22, 52) | 0.529 hours | Standard Deviation 0.7442 |
Comparison: Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: <0.000180% CI: [0.36707, 0.65345]Mixed Models Analysis
Comparison: Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.003180% CI: [0.21189, 0.51664]Mixed Models Analysis
Comparison: Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.155380% CI: [0.01366, 0.25882]Mixed Models Analysis
Comparison: Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.280980% CI: [-0.0205, 0.23458]Mixed Models Analysis
Comparison: Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.060380% CI: [0.07101, 0.36803]Mixed Models Analysis
Comparison: Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.p-value: 0.000880% CI: [0.27079, 0.58479]Mixed Models Analysis
Other Pre-specified
Number of Participants With Change From Baseline in Physical Examination and Neurological Examination
Analysis include general physical examination and assessment of head, ears, eyes, ocular fundi, nose, mouth, throat, neck, thyroid, lungs, heart, breasts, abdomen and musculoskeletal system.
Time frame: Baseline up to 1 week after last study dose (1 week after end of Period 2)
Population: Safety analysis set consisted of all participants who took at least 1 dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-03654746 (Low Dose) | Number of Participants With Change From Baseline in Physical Examination and Neurological Examination | 0 participants |
| PF-03654746 (Flexible Dose) | Number of Participants With Change From Baseline in Physical Examination and Neurological Examination | 0 participants |
| Placebo | Number of Participants With Change From Baseline in Physical Examination and Neurological Examination | 0 participants |
Other Pre-specified
Number of Participants With Clinically Significant Laboratory Test Abnormalities
Laboratory parameters included hematology (hemoglobin, hematocrit, red blood cell count, platelets, leukocytes, total neutrophils, eosinophils, basophils, lymphocytes, monocytes); liver function (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, albumin, total protein); renal function (creatinine, blood urea nitrogen, uric acid, sodium, potassium, chloride, bicarbonate, calcium); urinalysis (protein, blood), and clinical chemistry (glucose).
Time frame: Baseline up to 1 week after last study dose
Population: Safety analysis set consisted of all participants who took at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-03654746 (Low Dose) | Number of Participants With Clinically Significant Laboratory Test Abnormalities | 5 participants |
| PF-03654746 (Flexible Dose) | Number of Participants With Clinically Significant Laboratory Test Abnormalities | 9 participants |
| Placebo | Number of Participants With Clinically Significant Laboratory Test Abnormalities | 10 participants |
Other Pre-specified
Number of Participants With Clinically Significant Vital Sign Abnormalities
Criteria for potential clinical concern in vital signs: systolic blood pressure (BP) less than (\<) 90 millimeters of mercury (mmHg), diastolic BP \<50 mmHg, supine and sitting heart rate \<40 beats per minute (bpm) or \>120 bpm, standing and erect heart rate \<40 bpm or \>140 bpm. Maximum increase from baseline in systolic BP \>=30 mmHg, maximum increase from baseline in diastolic BP \>=20 mmHg.
Time frame: Baseline up to 1 week after last study dose
Population: Safety analysis set consisted of all participants who took at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-03654746 (Low Dose) | Number of Participants With Clinically Significant Vital Sign Abnormalities | 0 participants |
| PF-03654746 (Flexible Dose) | Number of Participants With Clinically Significant Vital Sign Abnormalities | 0 participants |
| Placebo | Number of Participants With Clinically Significant Vital Sign Abnormalities | 1 participants |
Other Pre-specified
Number of Participants With Electrocardiogram (ECG) Findings
Criteria for potential clinical concern in ECG parameters: maximum PR interval of greater than or equal to (\>=) 300 milliseconds (msec), maximum QRS interval \>=200 msec, maximum QTc interval of 450 to \<480 msec, 480 to \<500 msec and \>=500 msec.
Time frame: Baseline up to End of Treatment (Week 3 of period 2)
Population: Safety analysis set consisted of all participants who took at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-03654746 (Low Dose) | Number of Participants With Electrocardiogram (ECG) Findings | 1 participants |
| PF-03654746 (Flexible Dose) | Number of Participants With Electrocardiogram (ECG) Findings | 0 participants |
| Placebo | Number of Participants With Electrocardiogram (ECG) Findings | 1 participants |
Other Pre-specified
Treatment Duration
Treatment duration was defined as the total number of dosing days from first to last day of study drug administration in each period.
Time frame: Day 1 up to Day 21
Population: Safety analysis set consisted of all participants who took at least 1 dose of study medication.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PF-03654746 (Low Dose) | Treatment Duration | 21 days |
| PF-03654746 (Flexible Dose) | Treatment Duration | 21 days |
| Placebo | Treatment Duration | 21 days |