Schizophrenia
Conditions
Keywords
Schizophrenia, acute exacerbation, and PF-02545920
Brief summary
To assess the efficacy and safety of an investigational compound PF-02545920 for the treatment of schizophrenia. PF-02545920 will be more effective than placebo in reducing symptoms associated with schizophrenia.
Interventions
DRUGPF-02545920
Participants are assigned to 15 mg oral tablets twice a day of PF-02545920 or placebo in parallel for the duration of the study which is 21 days
DRUGPlacebo
Participants are assigned to 15 mg oral tablets twice a day of PF-02545920 or placebo in parallel for the duration of the study which is 21 days.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Have a current diagnosis of schizophrenia. 2. Increase in symptoms over the past 2-4 weeks. 3. Willing to remain inpatients for the duration of the trial.
Exclusion criteria
1. Evidence or history of clinically significant medical problems. 2. Females of childbearing potential. 3. A primary psychiatric diagnosis other than schizophrenia. 4. A diagnosis of substance abuse or dependence in the last 6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Total Score | Baseline (Day 1), Day 21 | PANSS is a clinician-rated instrument for assessing the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). PANSS total score is the sum of the 30 items and ranges from 30 to 210; where higher score indicates greater severity of symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Negative Subscale Score | Baseline (Day 1), Day 21 | PANSS is a clinician-rated instrument for assessing the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. PANSS negative subscale assesses negative symptoms associated with schizophrenia as blunted affect, emotional withdrawal, poor rapport, and passive/apathetic social withdrawal. It consists of 7 items and each item is rated on a scale from 1 (symptoms not present) to 7 (symptoms extremely severe). PANSS negative subscale score is the sum of 7 items and ranges from 7 to 49, where higher score indicates greater severity of symptoms. |
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: General Psychopathology Subscale Score | Baseline (Day 1), Day 21 | PANSS is a clinician-rated instrument for assessing the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. PANSS general psychopathology subscale score assesses general psychopathology symptoms associated with schizophrenia as somatic concern, anxiety, guilt feelings, tension, mannerisms/posturing, depression, motor retardation, uncooperativeness, unusual thought content, disoriented, poor attention, lack of judgment/insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance. It consists of 16 items and each item is rated on a scale from 1 (symptoms absent) to 7 (extreme psychopathology). PANSS general psychopathology subscale score is the sum of 16 items and ranges from 16 to 112; where higher scores indicates greater severity of symptoms. |
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Positive Marder Factor Score | Baseline (Day 1), Day 21 | PANSS subscales based on Marder factors assess negative symptoms, positive symptoms, disorganized thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor associated with schizophrenia. PANSS positive Marder factor score consists of 8 items and each item is rated on a scale from 1 (symptoms not present) to 7 (symptoms extremely severe). PANSS positive Marder factor score is the sum of 8 items and ranges from 8 to 56; where higher score indicating greater severity of symptoms. |
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Negative Marder Factor Score | Baseline (Day 1), Day 21 | PANSS subscales based on Marder factors assess negative symptoms, positive symptoms, disorganized thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor associated with schizophrenia. PANSS negative Marder factor score consists of 7 items and each item is rated on a scale from 1 (symptoms not present) to 7 (symptoms extremely severe). PANSS negative Marder factor score is the sum of 7 items and ranges from 7 to 49; where higher score indicating greater severity of symptoms. |
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Disorganized Thought Marder Factor Score | Baseline (Day 1), Day 21 | PANSS subscales based on Marder factors assess negative symptoms, positive symptoms, disorganized thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor associated with schizophrenia. PANSS disorganized thought Marder factor score consists of 7 items and each item is rated on a scale from 1 (symptoms not present) to 7 (symptoms extremely severe). PANSS disorganized thought Marder factor score is the sum of 7 items and ranges from 7 to 49; where higher score indicating greater severity of symptoms. |
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Hostility/Excitement Marder Factor Score | Baseline (Day 1), Day 21 | PANSS subscales based on Marder factors assess negative symptoms, positive symptoms, disorganized thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor associated with schizophrenia. PANSS hostility/excitement Marder factor score consists of 4 items and each item is rated on a scale from 1 (symptoms not present) to 7 (symptoms extremely severe). PANSS hostility/excitement Marder factor score is the sum of 4 items and ranges from 4 to 28; where higher score indicating greater severity of symptoms. |
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Positive Subscale Score | Baseline (Day 1), Day 21 | PANSS is a clinician-rated instrument for assessing the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. PANSS positive subscale assesses the positive symptoms associated with schizophrenia as delusions, conceptual disorganization, and hallucinatory behavior. It consists of 7 items and each item is rated on a scale from 1 (symptoms not present) to 7 (symptoms extremely severe). PANSS positive subscale is the sum of 7 items and ranges from 7 to 49; where higher score indicates greater severity of symptoms. |
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Derived Brief Psychiatric Rating Scale (BPRS) Core Psychosis Total Score | Baseline (Day 1), Day 21 | BPRS is a clinician-rated instrument for assessing conceptual disorganization, hallucinatory behavior, suspiciousness and unusual thought content associated with schizophrenia. The scale consists of 18 items. Each item is rated on a scale from 0 (symptom not present) to 6 (symptoms extremely severe). BPRS core psychosis total score is the sum of 18 items and ranges from 0 to 108; where higher score indicates greater severity of symptoms. |
| Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) Score at Day 21 | Baseline (Day 1), Day 21 | CGI-S is a 7-point clinician-rated scale for assessing the global severity of schizophrenia. Score range: 1 (normal - not ill at all) to 7 (most extreme illness). Higher score indicating greater degree of illness. |
| Change From Baseline in Clinical Global Impression Improvement Scale (CGI-I) Score at Day 21 | Baseline (Day 4), Day 21 | CGI-improvement is a 7-point clinician-rated scale for assessing the global improvement of schizophrenia ranging from 1 (very much improved) to 7 (very much worse). Higher score indicating less improvement. |
| Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 | Baseline (Day 1), Day 21 | NOSIE is an inpatient treatment staff-administered questionnaire. It consists of 30 items: 26 items divided into 6 subscales and 4 individual items. Each item is rated on a 5-point scale (0= never to 4= always), to assess functional ability of participants. 6 subscales: irritability (sum of 5 items: score range 0 to 20), manifest psychosis (sum of 4 items: score range 0 to 16), personal neatness (sum of 4 items: score range 0 to 16), retardation (sum of 3 items: score range 0 to 12), social competence (sum of 5 items: score range 0 to 20) and social interest (sum of 5 items: score range 0 to 20) and 4 individual items: cried (score range 0 to 4), refused to speak (score range 0 to 4), said felt blue or depressed (score range 0 to 4) and said he/she was no good (score range 0 to 4). For each of the 6 subscales and 4 individual items: higher scores indicates irregular functional ability. |
| Change From Baseline in Global Assessment of Functioning (GAF) Score at Day 21 | Baseline (Day 1), Day 21 | GAF is a single clinician-rated item to measure the severity of illness-related impairment in psychological, social and occupational functioning. It is a 100 point rating scale, score range: 0= worst functioning to 99= superior functioning, where higher scores indicates better functioning. |
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Anxiety/Depression Marder Factor Score | Baseline (Day 1), Day 21 | PANSS subscales based on Marder factors assess negative symptoms, positive symptoms, disorganized thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor associated with schizophrenia. PANSS anxiety/depression Marder factor score consists of 4 items and each item is rated on a scale from 1 (symptoms not present) to 7 (symptoms extremely severe). PANSS anxiety/depression Marder factor score is the sum of 4 items and ranges from 4 to 28; where higher score indicating greater severity of symptoms. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration Time Curve (AUC) of PF-02545920 | Hour 0 (pre-morning dose) on Day 7, 14, 21; 20 minutes post-dose on Day 7; 1.5, 4.5 hours post-dose on Day 14 and 24 hours post-dose on Day 21 | AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline (Day 1) up to Day 31 | An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 10 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events. |
| Steady State Average Concentration of PF-02545920 Over the Dosing Interval (Css,Avg) | Hour 0 (pre-morning dose) on Day 7, 14, 21; 20 minutes post-dose on Day 7; 1.5, 4.5 hours post-dose on Day 14 and 24 hours post-dose on Day 21 | — |
| Number of Participants With Vital Signs of Potential Clinical Concern | Baseline (Day 1) up to Day 31 | Criteria for vital signs of potential clinical concern: pulse rate (supine/sitting position) less than (\<) 40 or greater than (\>) 120 beats per minute (bpm), pulse rate in standing position \<40 or \>140 bpm; systolic blood pressure (SBP) \<90 millimeters of mercury (mm Hg) and greater than or equal to (\>=) 30 mm Hg change (increase, decrease) from baseline in same posture; diastolic blood pressure (DBP) \<50 mm Hg and \>=20 mm Hg change (increase, decrease) from baseline in same posture. |
| Number of Participants With Clinically Significant Physical and Neurological Examination Abnormalities | Baseline (Day 1) up to Day 31 | Analysis include general physical examination and assessment of head, ears, eyes, ocular fundi, nose, mouth, throat, neck, thyroid, lungs, heart, breasts, abdomen and musculoskeletal and neurological systems. Clinical significance was based on the investigator's discretion. |
| Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern | Baseline (Day 1) up to Day 31 | Criteria for ECG values for potential clinical concern: PR interval \>=300 millisecond (msec), \>=25 percent increase when baseline \>200 msec, and \>=50 percent increase when baseline less than or equal to (\<=) 200 msec; QRS interval \>=200 msec, \>=25 percent increase when baseline \>100 msec, and \>=50 percent increase when baseline \<=100 msec; QTcB interval (corrected QT interval using Bazett's formula) \>=500 msec. |
| Number of Participants With Laboratory Abnormalities | Baseline (Day 1) up to Day 31 | Criteria for laboratory abnormalities: Hemoglobin (Hgb), hematocrit, red blood cell (RBC) count: \<0.8\*lower limit of normal (LLN), platelet: \<0.5\*LLN or \>1.75\*upper limit of normal (ULN), white blood cell (WBC): \<0.6\*LLN or \>1.5\*ULN, lymphocyte, neutrophil: \<0.8\*LLN or \>1.2\*ULN, basophil, eosinophil, monocyte: \>1.2\*ULN; total bilirubin \>1.5\*ULN, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transferase, alkaline phosphatase: \> 3.0\*ULN, total protein, albumin: \<0.8\*LLN or\>1.2\*ULN; blood urea nitrogen, creatinine: \>1.3\*ULN, uric acid \>1.2\*ULN; cholesterol (HDL \<0.8\*LLN, LDL \>1.2\*ULN); sodium \<0.95\*LLN or \>1.05\*ULN, potassium, chloride, calcium, magnesium, bicarbonate: \<0.9\*LLN or \>1.1\*ULN, phosphate \<0.8\*LLN or \>1.2\*ULN; prolactin \>1.1\*ULN; glucose \<0.6\*LLN or \>1.5\*ULN, glycosylated hemoglobin \>1.3\*ULN, creatine kinase \>2.0\*ULN; urine (pH \<4.5 or \>8, glucose, ketone, protein, blood/Hgb \>=1, RBC, WBC \>=6). |
| Number of Participants With Abnormal Prolactin Level | Baseline (Day 1) up to Day 21 | Number of participants with abnormal values (\>1.1\* ULN) of prolactin level were reported. |
| Number of Participants With Abnormal High Density Lipoprotein (HDL) and Low Density Lipoprotein (LDL) Level | Baseline up to Day 21 | Number of participants with abnormal values of HDL level \<0.8\* LLN and LDL level \>1.2\*ULN were reported. |
| Number of Participants With Abnormal Glycosylated Hemoglobin (HbA1c) Level | Baseline (Day 1) up to Day 21 | Number of participants with abnormal values (\>1.3\* ULN) of HbA1c level were reported. |
| Number of Participants With Abnormal Fasting Insulin Level | Baseline (Day 1) up to Day 21 | Fasting glucose level below 6 micro international unit per milliliter (mcIU/mL) or above 27 mcIU/mL were considered as abnormal. Number of participants with abnormal values of fasting insulin level were reported. |
| Change From Baseline in Body Weight at Day 21 | Baseline (Day 1), Day 21 | — |
| Change From Baseline in Abdominal Girth at Day 21 | Baseline (Day 1), Day 21 | — |
| Change From Baseline in Extrapyramidal Symptom Rating Scale - Abbreviated (ESRS-A) Score at Day 21 | Baseline (Day 1), Day 21 | ESRS-A is an instrument used to assess extrapyramidal symptoms (including tremor and dystonic reactions). It assesses 4 items: Parkinsonism, dystonia, dyskinesia, and akathisia. Each item is scored on a 5-point severity scale ranging from 0 to 4, with higher score indicating greater severity of symptoms. |
| Change From Baseline in Stanford Sleepiness Scale (SSS) Score at Day 4, 7, 14 and 21 | Baseline (Day 1), Day 4, 7, 14, 21 | SSS is a 7-point Likert scale which facilitates standardized observation of alertness and rates sleepiness, where 1= alert/wide awake, 2= able to concentrate, 3= not at full alertness, 4= not at peak and let down, 5= beginning to lose interest in remaining awake, 6= sleepiness, 7= sleep onset soon; lost struggle to remain awake. Score ranging from 1 to 7, where higher score indicates more sleepiness. |
| Oral Clearance (CL/F) of PF-02545920 | Hour 0 (pre-morning dose) on Day 7, 14, 21; 20 minutes post-dose on Day 7; 1.5, 4.5 hours post-dose on Day 14 and 24 hours post-dose on Day 21 | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PF-02545920 15 Milligram (mg) Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31. | 24 |
| Placebo Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31. | 11 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 1 |
| Overall Study | Lack of Efficacy | 0 | 1 |
| Overall Study | Sponsor's Decision | 7 | 3 |
| Overall Study | Withdrawal by Subject | 4 | 3 |
Baseline characteristics
| Characteristic | PF-02545920 15 Milligram (mg) | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 42.3 years STANDARD_DEVIATION 9.3 | 43.1 years STANDARD_DEVIATION 10.8 | 42.6 years STANDARD_DEVIATION 9.7 |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 22 Participants | 9 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 22 / 24 | 9 / 11 |
| serious Total, serious adverse events | 5 / 24 | 0 / 11 |
Outcome results
Primary
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Total Score
PANSS is a clinician-rated instrument for assessing the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). PANSS total score is the sum of the 30 items and ranges from 30 to 210; where higher score indicates greater severity of symptoms.
Time frame: Baseline (Day 1), Day 21
Population: Pharmacodynamic data (PD) analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-02545920 15 Milligram (mg) | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Total Score | Baseline | 98.13 units on a scale | Standard Deviation 12.28 |
| PF-02545920 15 Milligram (mg) | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Total Score | Change at Day 21 | -19.82 units on a scale | Standard Deviation 19.06 |
| Placebo | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Total Score | Baseline | 96.10 units on a scale | Standard Deviation 4.61 |
| Placebo | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Total Score | Change at Day 21 | -18.25 units on a scale | Standard Deviation 24.09 |
Comparison: P-value and 90 percent confidence interval (CI) were obtained from mixed effects repeated measures analysis using covariance structures spatial power covariance structure (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.p-value: 0.8690% CI: [-16.49, 13.27]Mixed Models Analysis
Secondary
Change From Baseline in Clinical Global Impression Improvement Scale (CGI-I) Score at Day 21
CGI-improvement is a 7-point clinician-rated scale for assessing the global improvement of schizophrenia ranging from 1 (very much improved) to 7 (very much worse). Higher score indicating less improvement.
Time frame: Baseline (Day 4), Day 21
Population: PD analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-02545920 15 Milligram (mg) | Change From Baseline in Clinical Global Impression Improvement Scale (CGI-I) Score at Day 21 | Baseline | 3.3 units on a scale | Standard Deviation 0.93 |
| PF-02545920 15 Milligram (mg) | Change From Baseline in Clinical Global Impression Improvement Scale (CGI-I) Score at Day 21 | Change at Day 21 | 3.09 units on a scale | Standard Deviation 1.51 |
| Placebo | Change From Baseline in Clinical Global Impression Improvement Scale (CGI-I) Score at Day 21 | Baseline | 3.6 units on a scale | Standard Deviation 0.52 |
| Placebo | Change From Baseline in Clinical Global Impression Improvement Scale (CGI-I) Score at Day 21 | Change at Day 21 | 3 units on a scale | Standard Deviation 1.83 |
Comparison: P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects.p-value: 0.9990% CI: [-1.13, 1.14]Mixed Models Analysis
Secondary
Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) Score at Day 21
CGI-S is a 7-point clinician-rated scale for assessing the global severity of schizophrenia. Score range: 1 (normal - not ill at all) to 7 (most extreme illness). Higher score indicating greater degree of illness.
Time frame: Baseline (Day 1), Day 21
Population: PD analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-02545920 15 Milligram (mg) | Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) Score at Day 21 | Change at Day 21 | -0.91 units on a scale | Standard Deviation 0.701 |
| PF-02545920 15 Milligram (mg) | Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) Score at Day 21 | Baseline | 4.88 units on a scale | Standard Deviation 0.448 |
| Placebo | Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) Score at Day 21 | Baseline | 4.9 units on a scale | Standard Deviation 0.568 |
| Placebo | Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) Score at Day 21 | Change at Day 21 | -1 units on a scale | Standard Deviation 1.414 |
Comparison: P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.p-value: 0.9390% CI: [-0.84, 0.76]Mixed Models Analysis
Secondary
Change From Baseline in Global Assessment of Functioning (GAF) Score at Day 21
GAF is a single clinician-rated item to measure the severity of illness-related impairment in psychological, social and occupational functioning. It is a 100 point rating scale, score range: 0= worst functioning to 99= superior functioning, where higher scores indicates better functioning.
Time frame: Baseline (Day 1), Day 21
Population: PD analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-02545920 15 Milligram (mg) | Change From Baseline in Global Assessment of Functioning (GAF) Score at Day 21 | Baseline | 41.18 units on a scale | Standard Deviation 10.285 |
| PF-02545920 15 Milligram (mg) | Change From Baseline in Global Assessment of Functioning (GAF) Score at Day 21 | Change at Day 21 | 8.05 units on a scale | Standard Deviation 12.786 |
| Placebo | Change From Baseline in Global Assessment of Functioning (GAF) Score at Day 21 | Baseline | 40.78 units on a scale | Standard Deviation 9.497 |
| Placebo | Change From Baseline in Global Assessment of Functioning (GAF) Score at Day 21 | Change at Day 21 | 2.33 units on a scale | Standard Deviation 10.677 |
90% CI: [-14.42, 25.845]
Secondary
Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21
NOSIE is an inpatient treatment staff-administered questionnaire. It consists of 30 items: 26 items divided into 6 subscales and 4 individual items. Each item is rated on a 5-point scale (0= never to 4= always), to assess functional ability of participants. 6 subscales: irritability (sum of 5 items: score range 0 to 20), manifest psychosis (sum of 4 items: score range 0 to 16), personal neatness (sum of 4 items: score range 0 to 16), retardation (sum of 3 items: score range 0 to 12), social competence (sum of 5 items: score range 0 to 20) and social interest (sum of 5 items: score range 0 to 20) and 4 individual items: cried (score range 0 to 4), refused to speak (score range 0 to 4), said felt blue or depressed (score range 0 to 4) and said he/she was no good (score range 0 to 4). For each of the 6 subscales and 4 individual items: higher scores indicates irregular functional ability.
Time frame: Baseline (Day 1), Day 21
Population: PD analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-02545920 15 Milligram (mg) | Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 | Baseline: Cried | 0.26 units on a scale | Standard Deviation 0.933 |
| PF-02545920 15 Milligram (mg) | Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 | Change at Day 21: Cried | -0.16 units on a scale | Standard Deviation 0.958 |
| PF-02545920 15 Milligram (mg) | Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 | Baseline: Felt blue or depressed | 0.63 units on a scale | Standard Deviation 0.761 |
| PF-02545920 15 Milligram (mg) | Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 | Change at Day 21: Felt blue or depressed | 0 units on a scale | Standard Deviation 0.882 |
| PF-02545920 15 Milligram (mg) | Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 | Baseline: Irritability | 2.47 units on a scale | Standard Deviation 2.611 |
| PF-02545920 15 Milligram (mg) | Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 | Change at Day 21: Irritability | 1.21 units on a scale | Standard Deviation 4.063 |
| PF-02545920 15 Milligram (mg) | Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 | Baseline: Manifest psychosis | 2.37 units on a scale | Standard Deviation 2.314 |
| PF-02545920 15 Milligram (mg) | Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 | Change at Day 21: Manifest psychosis | -0.32 units on a scale | Standard Deviation 2.868 |
| PF-02545920 15 Milligram (mg) | Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 | Baseline: Personal neatness | 11.95 units on a scale | Standard Deviation 3.535 |
| PF-02545920 15 Milligram (mg) | Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 | Change at Day 21: Personal neatness | 0 units on a scale | Standard Deviation 2.236 |
| PF-02545920 15 Milligram (mg) | Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 | Baseline: Refused to speak | 0.32 units on a scale | Standard Deviation 0.582 |
| PF-02545920 15 Milligram (mg) | Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 | Change at Day 21: Refused to speak | -0.11 units on a scale | Standard Deviation 0.567 |
| PF-02545920 15 Milligram (mg) | Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 | Baseline: Retardation | 4.05 units on a scale | Standard Deviation 2.527 |
| PF-02545920 15 Milligram (mg) | Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 | Change at Day 21: Retardation | -0.63 units on a scale | Standard Deviation 3.077 |
| PF-02545920 15 Milligram (mg) | Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 | Baseline: Said he/she was no good | 0.26 units on a scale | Standard Deviation 0.452 |
| PF-02545920 15 Milligram (mg) | Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 | Change at Day 21: Said he/she was no good | 0.05 units on a scale | Standard Deviation 0.621 |
| PF-02545920 15 Milligram (mg) | Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 | Baseline: Social competence | 17.37 units on a scale | Standard Deviation 3.847 |
| PF-02545920 15 Milligram (mg) | Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 | Change at Day 21: Social competence | 0.11 units on a scale | Standard Deviation 2.233 |
| PF-02545920 15 Milligram (mg) | Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 | Baseline: Social interest | 6.84 units on a scale | Standard Deviation 3.516 |
| PF-02545920 15 Milligram (mg) | Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 | Change at Day 21: Social interest | 1.16 units on a scale | Standard Deviation 3.775 |
| Placebo | Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 | Change at Day 21: Social competence | 0.67 units on a scale | Standard Deviation 3.354 |
| Placebo | Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 | Baseline: Cried | 0.22 units on a scale | Standard Deviation 0.441 |
| Placebo | Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 | Baseline: Refused to speak | 0 units on a scale | Standard Deviation 0 |
| Placebo | Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 | Change at Day 21: Cried | 0 units on a scale | Standard Deviation 0.5 |
| Placebo | Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 | Change at Day 21: Said he/she was no good | 0.22 units on a scale | Standard Deviation 0.441 |
| Placebo | Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 | Baseline: Felt blue or depressed | 1.11 units on a scale | Standard Deviation 1.269 |
| Placebo | Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 | Change at Day 21: Refused to speak | 0.22 units on a scale | Standard Deviation 0.441 |
| Placebo | Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 | Change at Day 21: Felt blue or depressed | -0.44 units on a scale | Standard Deviation 1.424 |
| Placebo | Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 | Change at Day 21: Social interest | 1.78 units on a scale | Standard Deviation 5.674 |
| Placebo | Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 | Baseline: Irritability | 3.67 units on a scale | Standard Deviation 5.958 |
| Placebo | Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 | Baseline: Retardation | 3.67 units on a scale | Standard Deviation 1.323 |
| Placebo | Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 | Change at Day 21: Irritability | -0.33 units on a scale | Standard Deviation 4.848 |
| Placebo | Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 | Baseline: Social competence | 17.44 units on a scale | Standard Deviation 2.242 |
| Placebo | Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 | Baseline: Manifest psychosis | 3.78 units on a scale | Standard Deviation 3.27 |
| Placebo | Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 | Change at Day 21: Retardation | 0 units on a scale | Standard Deviation 1.803 |
| Placebo | Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 | Change at Day 21: Manifest psychosis | -0.89 units on a scale | Standard Deviation 3.14 |
| Placebo | Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 | Baseline: Social interest | 8.89 units on a scale | Standard Deviation 2.522 |
| Placebo | Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 | Baseline: Personal neatness | 11.11 units on a scale | Standard Deviation 4.256 |
| Placebo | Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 | Baseline: Said he/she was no good | 0.22 units on a scale | Standard Deviation 0.441 |
| Placebo | Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21 | Change at Day 21: Personal neatness | -0.56 units on a scale | Standard Deviation 1.74 |
Comparison: Change at Day 21: Felt blue or depressed90% CI: [-1.329, 2.218]
Comparison: Change at Day 21: Cried90% CI: [-1.546, 1.231]
Comparison: Change at Day 21: Irritability90% CI: [-5.561, 8.649]
Comparison: Change at Day 21: Manifest psychosis90% CI: [-4.287, 5.433]
Comparison: Change at Day 21: Personal neatness90% CI: [-2.892, 4.003]
Comparison: Change at Day 21: Refused to speak90% CI: [-1.202, 0.547]
Comparison: Change at Day 21: Retardation90% CI: [-5.152, 3.889]
Comparison: Change at Day 21: Said he/she was no good90% CI: [-1.11, 0.771]
Comparison: Change at Day 21: Social competence90% CI: [-4.887, 3.764]
Comparison: Change at Day 21: Social interest90% CI: [-7.934, 6.694]
Secondary
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Anxiety/Depression Marder Factor Score
PANSS subscales based on Marder factors assess negative symptoms, positive symptoms, disorganized thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor associated with schizophrenia. PANSS anxiety/depression Marder factor score consists of 4 items and each item is rated on a scale from 1 (symptoms not present) to 7 (symptoms extremely severe). PANSS anxiety/depression Marder factor score is the sum of 4 items and ranges from 4 to 28; where higher score indicating greater severity of symptoms.
Time frame: Baseline (Day 1), Day 21
Population: PD analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-02545920 15 Milligram (mg) | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Anxiety/Depression Marder Factor Score | Baseline | 13.21 units on a scale | Standard Deviation 2.34 |
| PF-02545920 15 Milligram (mg) | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Anxiety/Depression Marder Factor Score | Change at Day 21 | -2.73 units on a scale | Standard Deviation 3.64 |
| Placebo | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Anxiety/Depression Marder Factor Score | Baseline | 14.30 units on a scale | Standard Deviation 2.75 |
| Placebo | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Anxiety/Depression Marder Factor Score | Change at Day 21 | -4.25 units on a scale | Standard Deviation 2.87 |
Comparison: P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.p-value: 0.690% CI: [-1.85, 3.54]Mixed Models Analysis
Secondary
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Derived Brief Psychiatric Rating Scale (BPRS) Core Psychosis Total Score
BPRS is a clinician-rated instrument for assessing conceptual disorganization, hallucinatory behavior, suspiciousness and unusual thought content associated with schizophrenia. The scale consists of 18 items. Each item is rated on a scale from 0 (symptom not present) to 6 (symptoms extremely severe). BPRS core psychosis total score is the sum of 18 items and ranges from 0 to 108; where higher score indicates greater severity of symptoms.
Time frame: Baseline (Day 1), Day 21
Population: PD analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-02545920 15 Milligram (mg) | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Derived Brief Psychiatric Rating Scale (BPRS) Core Psychosis Total Score | Baseline | 17.17 units on a scale | Standard Deviation 2.35 |
| PF-02545920 15 Milligram (mg) | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Derived Brief Psychiatric Rating Scale (BPRS) Core Psychosis Total Score | Change at Day 21 | -3.55 units on a scale | Standard Deviation 3.24 |
| Placebo | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Derived Brief Psychiatric Rating Scale (BPRS) Core Psychosis Total Score | Baseline | 17.60 units on a scale | Standard Deviation 1.65 |
| Placebo | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Derived Brief Psychiatric Rating Scale (BPRS) Core Psychosis Total Score | Change at Day 21 | -4.25 units on a scale | Standard Deviation 5.5 |
Comparison: P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.p-value: 0.8190% CI: [-2.65, 3.53]Mixed Models Analysis
Secondary
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Disorganized Thought Marder Factor Score
PANSS subscales based on Marder factors assess negative symptoms, positive symptoms, disorganized thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor associated with schizophrenia. PANSS disorganized thought Marder factor score consists of 7 items and each item is rated on a scale from 1 (symptoms not present) to 7 (symptoms extremely severe). PANSS disorganized thought Marder factor score is the sum of 7 items and ranges from 7 to 49; where higher score indicating greater severity of symptoms.
Time frame: Baseline (Day 1), Day 21
Population: PD analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-02545920 15 Milligram (mg) | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Disorganized Thought Marder Factor Score | Baseline | 22.92 units on a scale | Standard Deviation 5.42 |
| PF-02545920 15 Milligram (mg) | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Disorganized Thought Marder Factor Score | Change at Day 21 | -4.18 units on a scale | Standard Deviation 5.1 |
| Placebo | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Disorganized Thought Marder Factor Score | Baseline | 21.50 units on a scale | Standard Deviation 3.41 |
| Placebo | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Disorganized Thought Marder Factor Score | Change at Day 21 | -3.50 units on a scale | Standard Deviation 4.8 |
Comparison: P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.p-value: 0.7890% CI: [-3.17, 4.43]Mixed Models Analysis
Secondary
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: General Psychopathology Subscale Score
PANSS is a clinician-rated instrument for assessing the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. PANSS general psychopathology subscale score assesses general psychopathology symptoms associated with schizophrenia as somatic concern, anxiety, guilt feelings, tension, mannerisms/posturing, depression, motor retardation, uncooperativeness, unusual thought content, disoriented, poor attention, lack of judgment/insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance. It consists of 16 items and each item is rated on a scale from 1 (symptoms absent) to 7 (extreme psychopathology). PANSS general psychopathology subscale score is the sum of 16 items and ranges from 16 to 112; where higher scores indicates greater severity of symptoms.
Time frame: Baseline (Day 1), Day 21
Population: PD analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-02545920 15 Milligram (mg) | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: General Psychopathology Subscale Score | Baseline | 47.83 units on a scale | Standard Deviation 6.88 |
| PF-02545920 15 Milligram (mg) | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: General Psychopathology Subscale Score | Change at Day 21 | -8.36 units on a scale | Standard Deviation 10.04 |
| Placebo | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: General Psychopathology Subscale Score | Baseline | 48.70 units on a scale | Standard Deviation 3.59 |
| Placebo | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: General Psychopathology Subscale Score | Change at Day 21 | -9.25 units on a scale | Standard Deviation 9.78 |
Comparison: P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.p-value: 0.8690% CI: [-6.21, 7.69]Mixed Models Analysis
Secondary
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Hostility/Excitement Marder Factor Score
PANSS subscales based on Marder factors assess negative symptoms, positive symptoms, disorganized thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor associated with schizophrenia. PANSS hostility/excitement Marder factor score consists of 4 items and each item is rated on a scale from 1 (symptoms not present) to 7 (symptoms extremely severe). PANSS hostility/excitement Marder factor score is the sum of 4 items and ranges from 4 to 28; where higher score indicating greater severity of symptoms.
Time frame: Baseline (Day 1), Day 21
Population: PD analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-02545920 15 Milligram (mg) | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Hostility/Excitement Marder Factor Score | Baseline | 9.33 units on a scale | Standard Deviation 3.58 |
| PF-02545920 15 Milligram (mg) | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Hostility/Excitement Marder Factor Score | Change at Day 21 | -0.45 units on a scale | Standard Deviation 3.11 |
| Placebo | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Hostility/Excitement Marder Factor Score | Baseline | 10.80 units on a scale | Standard Deviation 3.05 |
| Placebo | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Hostility/Excitement Marder Factor Score | Change at Day 21 | -1.25 units on a scale | Standard Deviation 2.06 |
Comparison: P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.p-value: 0.9290% CI: [-2.11, 2.39]Mixed Models Analysis
Secondary
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Negative Marder Factor Score
PANSS subscales based on Marder factors assess negative symptoms, positive symptoms, disorganized thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor associated with schizophrenia. PANSS negative Marder factor score consists of 7 items and each item is rated on a scale from 1 (symptoms not present) to 7 (symptoms extremely severe). PANSS negative Marder factor score is the sum of 7 items and ranges from 7 to 49; where higher score indicating greater severity of symptoms.
Time frame: Baseline (Day 1), Day 21
Population: PD analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-02545920 15 Milligram (mg) | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Negative Marder Factor Score | Baseline | 22.63 units on a scale | Standard Deviation 5.5 |
| PF-02545920 15 Milligram (mg) | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Negative Marder Factor Score | Change at Day 21 | -6.27 units on a scale | Standard Deviation 5.83 |
| Placebo | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Negative Marder Factor Score | Baseline | 20.30 units on a scale | Standard Deviation 4.11 |
| Placebo | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Negative Marder Factor Score | Change at Day 21 | -5.75 units on a scale | Standard Deviation 8.3 |
Comparison: P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.p-value: 0.9190% CI: [-4.76, 4.16]Mixed Models Analysis
Secondary
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Negative Subscale Score
PANSS is a clinician-rated instrument for assessing the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. PANSS negative subscale assesses negative symptoms associated with schizophrenia as blunted affect, emotional withdrawal, poor rapport, and passive/apathetic social withdrawal. It consists of 7 items and each item is rated on a scale from 1 (symptoms not present) to 7 (symptoms extremely severe). PANSS negative subscale score is the sum of 7 items and ranges from 7 to 49, where higher score indicates greater severity of symptoms.
Time frame: Baseline (Day 1), Day 21
Population: PD analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-02545920 15 Milligram (mg) | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Negative Subscale Score | Baseline | 24.17 units on a scale | Standard Deviation 5.31 |
| PF-02545920 15 Milligram (mg) | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Negative Subscale Score | Change at Day 21 | -5.91 units on a scale | Standard Deviation 5.86 |
| Placebo | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Negative Subscale Score | Baseline | 20.90 units on a scale | Standard Deviation 3.54 |
| Placebo | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Negative Subscale Score | Change at Day 21 | -4.50 units on a scale | Standard Deviation 7.85 |
Comparison: P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.p-value: 0.9390% CI: [-4.59, 4.1]Mixed Models Analysis
Secondary
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Positive Marder Factor Score
PANSS subscales based on Marder factors assess negative symptoms, positive symptoms, disorganized thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor associated with schizophrenia. PANSS positive Marder factor score consists of 8 items and each item is rated on a scale from 1 (symptoms not present) to 7 (symptoms extremely severe). PANSS positive Marder factor score is the sum of 8 items and ranges from 8 to 56; where higher score indicating greater severity of symptoms.
Time frame: Baseline (Day 1), Day 21
Population: PD analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-02545920 15 Milligram (mg) | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Positive Marder Factor Score | Baseline | 30.04 units on a scale | Standard Deviation 3.47 |
| PF-02545920 15 Milligram (mg) | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Positive Marder Factor Score | Change at Day 21 | -6.18 units on a scale | Standard Deviation 5.67 |
| Placebo | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Positive Marder Factor Score | Baseline | 29.20 units on a scale | Standard Deviation 2.35 |
| Placebo | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Positive Marder Factor Score | Change at Day 21 | -3.50 units on a scale | Standard Deviation 9.15 |
Comparison: P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.p-value: 0.4390% CI: [-7.92, 2.79]Mixed Models Analysis
Secondary
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Positive Subscale Score
PANSS is a clinician-rated instrument for assessing the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. PANSS positive subscale assesses the positive symptoms associated with schizophrenia as delusions, conceptual disorganization, and hallucinatory behavior. It consists of 7 items and each item is rated on a scale from 1 (symptoms not present) to 7 (symptoms extremely severe). PANSS positive subscale is the sum of 7 items and ranges from 7 to 49; where higher score indicates greater severity of symptoms.
Time frame: Baseline (Day 1), Day 21
Population: PD analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-02545920 15 Milligram (mg) | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Positive Subscale Score | Baseline | 26.13 units on a scale | Standard Deviation 3.31 |
| PF-02545920 15 Milligram (mg) | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Positive Subscale Score | Change at Day 21 | -5.55 units on a scale | Standard Deviation 4.87 |
| Placebo | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Positive Subscale Score | Baseline | 26.50 units on a scale | Standard Deviation 2.17 |
| Placebo | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Positive Subscale Score | Change at Day 21 | -4.50 units on a scale | Standard Deviation 7.55 |
Comparison: P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.p-value: 0.6590% CI: [-5.71, 3.24]Mixed Models Analysis
Other Pre-specified
Area Under the Concentration Time Curve (AUC) of PF-02545920
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
Time frame: Hour 0 (pre-morning dose) on Day 7, 14, 21; 20 minutes post-dose on Day 7; 1.5, 4.5 hours post-dose on Day 14 and 24 hours post-dose on Day 21
Population: Data was not collected for this outcome measure, due to early termination of the study and the limited number of participants dosed with PF-02545920 resulted in insufficient PK sampling to support development of a model to calculate the PK parameters.
Other Pre-specified
Change From Baseline in Abdominal Girth at Day 21
Time frame: Baseline (Day 1), Day 21
Population: Safety analysis set included all participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-02545920 15 Milligram (mg) | Change From Baseline in Abdominal Girth at Day 21 | Baseline | 86.57 centimeter | Standard Deviation 19.654 |
| PF-02545920 15 Milligram (mg) | Change From Baseline in Abdominal Girth at Day 21 | Change at Day 21 | 1.64 centimeter | Standard Deviation 6.701 |
| Placebo | Change From Baseline in Abdominal Girth at Day 21 | Baseline | 90.15 centimeter | Standard Deviation 14.87 |
| Placebo | Change From Baseline in Abdominal Girth at Day 21 | Change at Day 21 | 5.83 centimeter | Standard Deviation 13.818 |
90% CI: [-19.5, 11.114]
Other Pre-specified
Change From Baseline in Body Weight at Day 21
Time frame: Baseline (Day 1), Day 21
Population: Safety analysis set included all participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-02545920 15 Milligram (mg) | Change From Baseline in Body Weight at Day 21 | Baseline | 87.48 kilogram | Standard Deviation 28.977 |
| PF-02545920 15 Milligram (mg) | Change From Baseline in Body Weight at Day 21 | Change at Day 21 | -1.07 kilogram | Standard Deviation 4.468 |
| Placebo | Change From Baseline in Body Weight at Day 21 | Baseline | 85.82 kilogram | Standard Deviation 16.969 |
| Placebo | Change From Baseline in Body Weight at Day 21 | Change at Day 21 | -0.22 kilogram | Standard Deviation 3.567 |
90% CI: [-7.807, 6.109]
Other Pre-specified
Change From Baseline in Extrapyramidal Symptom Rating Scale - Abbreviated (ESRS-A) Score at Day 21
ESRS-A is an instrument used to assess extrapyramidal symptoms (including tremor and dystonic reactions). It assesses 4 items: Parkinsonism, dystonia, dyskinesia, and akathisia. Each item is scored on a 5-point severity scale ranging from 0 to 4, with higher score indicating greater severity of symptoms.
Time frame: Baseline (Day 1), Day 21
Population: Safety analysis set included all participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-02545920 15 Milligram (mg) | Change From Baseline in Extrapyramidal Symptom Rating Scale - Abbreviated (ESRS-A) Score at Day 21 | Baseline: Parkinsonism | 2.5 units on a scale | Standard Deviation 2.919 |
| PF-02545920 15 Milligram (mg) | Change From Baseline in Extrapyramidal Symptom Rating Scale - Abbreviated (ESRS-A) Score at Day 21 | Change at Day 21: Parkinsonism | -0.27 units on a scale | Standard Deviation 3.952 |
| PF-02545920 15 Milligram (mg) | Change From Baseline in Extrapyramidal Symptom Rating Scale - Abbreviated (ESRS-A) Score at Day 21 | Baseline: Dyskinesia | 0.58 units on a scale | Standard Deviation 1.472 |
| PF-02545920 15 Milligram (mg) | Change From Baseline in Extrapyramidal Symptom Rating Scale - Abbreviated (ESRS-A) Score at Day 21 | Change at Day 21: Dyskinesia | 0.82 units on a scale | Standard Deviation 3.371 |
| PF-02545920 15 Milligram (mg) | Change From Baseline in Extrapyramidal Symptom Rating Scale - Abbreviated (ESRS-A) Score at Day 21 | Baseline: Dystonia | 0.29 units on a scale | Standard Deviation 1.083 |
| PF-02545920 15 Milligram (mg) | Change From Baseline in Extrapyramidal Symptom Rating Scale - Abbreviated (ESRS-A) Score at Day 21 | Change at Day 21: Dystonia | -0.18 units on a scale | Standard Deviation 1.401 |
| PF-02545920 15 Milligram (mg) | Change From Baseline in Extrapyramidal Symptom Rating Scale - Abbreviated (ESRS-A) Score at Day 21 | Baseline: Akathisia | 0.54 units on a scale | Standard Deviation 1.215 |
| PF-02545920 15 Milligram (mg) | Change From Baseline in Extrapyramidal Symptom Rating Scale - Abbreviated (ESRS-A) Score at Day 21 | Change at Day 21: Akathisia | 0.45 units on a scale | Standard Deviation 1.864 |
| Placebo | Change From Baseline in Extrapyramidal Symptom Rating Scale - Abbreviated (ESRS-A) Score at Day 21 | Change at Day 21: Akathisia | -0.25 units on a scale | Standard Deviation 0.5 |
| Placebo | Change From Baseline in Extrapyramidal Symptom Rating Scale - Abbreviated (ESRS-A) Score at Day 21 | Baseline: Parkinsonism | 1.7 units on a scale | Standard Deviation 2.058 |
| Placebo | Change From Baseline in Extrapyramidal Symptom Rating Scale - Abbreviated (ESRS-A) Score at Day 21 | Baseline: Dystonia | 0.3 units on a scale | Standard Deviation 0.675 |
| Placebo | Change From Baseline in Extrapyramidal Symptom Rating Scale - Abbreviated (ESRS-A) Score at Day 21 | Change at Day 21: Parkinsonism | 0 units on a scale | Standard Deviation 0.816 |
| Placebo | Change From Baseline in Extrapyramidal Symptom Rating Scale - Abbreviated (ESRS-A) Score at Day 21 | Baseline: Akathisia | 0.7 units on a scale | Standard Deviation 1.337 |
| Placebo | Change From Baseline in Extrapyramidal Symptom Rating Scale - Abbreviated (ESRS-A) Score at Day 21 | Baseline: Dyskinesia | 0.6 units on a scale | Standard Deviation 1.075 |
| Placebo | Change From Baseline in Extrapyramidal Symptom Rating Scale - Abbreviated (ESRS-A) Score at Day 21 | Change at Day 21: Dystonia | 0.75 units on a scale | Standard Deviation 1.5 |
| Placebo | Change From Baseline in Extrapyramidal Symptom Rating Scale - Abbreviated (ESRS-A) Score at Day 21 | Change at Day 21: Dyskinesia | 1 units on a scale | Standard Deviation 1.155 |
Comparison: Change at Day 21: Parkinsonism90% CI: [-6.01, 5.465]
Comparison: Change at Day 21: Dyskinesia90% CI: [-5.13, 4.766]
Comparison: Change at Day 21: Dystonia90% CI: [-3.275, 1.411]
Comparison: Change at Day 21: Akathisia90% CI: [-2.013, 3.422]
Other Pre-specified
Change From Baseline in Stanford Sleepiness Scale (SSS) Score at Day 4, 7, 14 and 21
SSS is a 7-point Likert scale which facilitates standardized observation of alertness and rates sleepiness, where 1= alert/wide awake, 2= able to concentrate, 3= not at full alertness, 4= not at peak and let down, 5= beginning to lose interest in remaining awake, 6= sleepiness, 7= sleep onset soon; lost struggle to remain awake. Score ranging from 1 to 7, where higher score indicates more sleepiness.
Time frame: Baseline (Day 1), Day 4, 7, 14, 21
Population: Safety analysis set included all participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-02545920 15 Milligram (mg) | Change From Baseline in Stanford Sleepiness Scale (SSS) Score at Day 4, 7, 14 and 21 | Change at Day 4 | -0.09 units on a scale | Standard Deviation 1.019 |
| PF-02545920 15 Milligram (mg) | Change From Baseline in Stanford Sleepiness Scale (SSS) Score at Day 4, 7, 14 and 21 | Change at Day 14 | -0.23 units on a scale | Standard Deviation 1.536 |
| PF-02545920 15 Milligram (mg) | Change From Baseline in Stanford Sleepiness Scale (SSS) Score at Day 4, 7, 14 and 21 | Change at Day 7 | 0.11 units on a scale | Standard Deviation 1.243 |
| PF-02545920 15 Milligram (mg) | Change From Baseline in Stanford Sleepiness Scale (SSS) Score at Day 4, 7, 14 and 21 | Change at Day 21 | -0.4 units on a scale | Standard Deviation 1.075 |
| PF-02545920 15 Milligram (mg) | Change From Baseline in Stanford Sleepiness Scale (SSS) Score at Day 4, 7, 14 and 21 | Baseline | 2.3 units on a scale | Standard Deviation 0.926 |
| Placebo | Change From Baseline in Stanford Sleepiness Scale (SSS) Score at Day 4, 7, 14 and 21 | Change at Day 21 | -0.5 units on a scale | Standard Deviation 1.291 |
| Placebo | Change From Baseline in Stanford Sleepiness Scale (SSS) Score at Day 4, 7, 14 and 21 | Baseline | 2 units on a scale | Standard Deviation 1.054 |
| Placebo | Change From Baseline in Stanford Sleepiness Scale (SSS) Score at Day 4, 7, 14 and 21 | Change at Day 4 | 0.2 units on a scale | Standard Deviation 1.549 |
| Placebo | Change From Baseline in Stanford Sleepiness Scale (SSS) Score at Day 4, 7, 14 and 21 | Change at Day 7 | -0.22 units on a scale | Standard Deviation 1.563 |
| Placebo | Change From Baseline in Stanford Sleepiness Scale (SSS) Score at Day 4, 7, 14 and 21 | Change at Day 14 | -0.67 units on a scale | Standard Deviation 1.211 |
Comparison: Change at Day 490% CI: [-2.27, 1.688]
Comparison: Change at Day 790% CI: [-1.892, 2.547]
Comparison: Change at Day 1490% CI: [-1.946, 2.817]
Comparison: Change at Day 2190% CI: [-1.763, 1.963]
Other Pre-specified
Number of Participants With Abnormal Fasting Insulin Level
Fasting glucose level below 6 micro international unit per milliliter (mcIU/mL) or above 27 mcIU/mL were considered as abnormal. Number of participants with abnormal values of fasting insulin level were reported.
Time frame: Baseline (Day 1) up to Day 21
Population: Safety analysis set included all participants who received at least 1 dose of study medication. Here, 'N' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-02545920 15 Milligram (mg) | Number of Participants With Abnormal Fasting Insulin Level | 13 participants |
| Placebo | Number of Participants With Abnormal Fasting Insulin Level | 4 participants |
Other Pre-specified
Number of Participants With Abnormal Glycosylated Hemoglobin (HbA1c) Level
Number of participants with abnormal values (\>1.3\* ULN) of HbA1c level were reported.
Time frame: Baseline (Day 1) up to Day 21
Population: Safety analysis set included all participants who received at least 1 dose of study medication. Here, 'N' signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-02545920 15 Milligram (mg) | Number of Participants With Abnormal Glycosylated Hemoglobin (HbA1c) Level | 3 participants |
| Placebo | Number of Participants With Abnormal Glycosylated Hemoglobin (HbA1c) Level | 0 participants |
Other Pre-specified
Number of Participants With Abnormal High Density Lipoprotein (HDL) and Low Density Lipoprotein (LDL) Level
Number of participants with abnormal values of HDL level \<0.8\* LLN and LDL level \>1.2\*ULN were reported.
Time frame: Baseline up to Day 21
Population: Safety analysis set included all participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-02545920 15 Milligram (mg) | Number of Participants With Abnormal High Density Lipoprotein (HDL) and Low Density Lipoprotein (LDL) Level | HDL <0.8*LLN | 0 participants |
| PF-02545920 15 Milligram (mg) | Number of Participants With Abnormal High Density Lipoprotein (HDL) and Low Density Lipoprotein (LDL) Level | LDL >1.2*ULN | 3 participants |
| Placebo | Number of Participants With Abnormal High Density Lipoprotein (HDL) and Low Density Lipoprotein (LDL) Level | HDL <0.8*LLN | 1 participants |
| Placebo | Number of Participants With Abnormal High Density Lipoprotein (HDL) and Low Density Lipoprotein (LDL) Level | LDL >1.2*ULN | 0 participants |
Other Pre-specified
Number of Participants With Abnormal Prolactin Level
Number of participants with abnormal values (\>1.1\* ULN) of prolactin level were reported.
Time frame: Baseline (Day 1) up to Day 21
Population: Safety analysis set included all participants who received at least 1 dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-02545920 15 Milligram (mg) | Number of Participants With Abnormal Prolactin Level | 2 participants |
| Placebo | Number of Participants With Abnormal Prolactin Level | 0 participants |
Other Pre-specified
Number of Participants With Clinically Significant Physical and Neurological Examination Abnormalities
Analysis include general physical examination and assessment of head, ears, eyes, ocular fundi, nose, mouth, throat, neck, thyroid, lungs, heart, breasts, abdomen and musculoskeletal and neurological systems. Clinical significance was based on the investigator's discretion.
Time frame: Baseline (Day 1) up to Day 31
Population: Safety analysis set included all participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-02545920 15 Milligram (mg) | Number of Participants With Clinically Significant Physical and Neurological Examination Abnormalities | Physical examination | 0 participants |
| PF-02545920 15 Milligram (mg) | Number of Participants With Clinically Significant Physical and Neurological Examination Abnormalities | Neurological examination | 0 participants |
| Placebo | Number of Participants With Clinically Significant Physical and Neurological Examination Abnormalities | Physical examination | 0 participants |
| Placebo | Number of Participants With Clinically Significant Physical and Neurological Examination Abnormalities | Neurological examination | 0 participants |
Other Pre-specified
Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern
Criteria for ECG values for potential clinical concern: PR interval \>=300 millisecond (msec), \>=25 percent increase when baseline \>200 msec, and \>=50 percent increase when baseline less than or equal to (\<=) 200 msec; QRS interval \>=200 msec, \>=25 percent increase when baseline \>100 msec, and \>=50 percent increase when baseline \<=100 msec; QTcB interval (corrected QT interval using Bazett's formula) \>=500 msec.
Time frame: Baseline (Day 1) up to Day 31
Population: Safety analysis set included all participants who received at least 1 dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-02545920 15 Milligram (mg) | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern | 0 participants |
| Placebo | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern | 0 participants |
Other Pre-specified
Number of Participants With Laboratory Abnormalities
Criteria for laboratory abnormalities: Hemoglobin (Hgb), hematocrit, red blood cell (RBC) count: \<0.8\*lower limit of normal (LLN), platelet: \<0.5\*LLN or \>1.75\*upper limit of normal (ULN), white blood cell (WBC): \<0.6\*LLN or \>1.5\*ULN, lymphocyte, neutrophil: \<0.8\*LLN or \>1.2\*ULN, basophil, eosinophil, monocyte: \>1.2\*ULN; total bilirubin \>1.5\*ULN, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transferase, alkaline phosphatase: \> 3.0\*ULN, total protein, albumin: \<0.8\*LLN or\>1.2\*ULN; blood urea nitrogen, creatinine: \>1.3\*ULN, uric acid \>1.2\*ULN; cholesterol (HDL \<0.8\*LLN, LDL \>1.2\*ULN); sodium \<0.95\*LLN or \>1.05\*ULN, potassium, chloride, calcium, magnesium, bicarbonate: \<0.9\*LLN or \>1.1\*ULN, phosphate \<0.8\*LLN or \>1.2\*ULN; prolactin \>1.1\*ULN; glucose \<0.6\*LLN or \>1.5\*ULN, glycosylated hemoglobin \>1.3\*ULN, creatine kinase \>2.0\*ULN; urine (pH \<4.5 or \>8, glucose, ketone, protein, blood/Hgb \>=1, RBC, WBC \>=6).
Time frame: Baseline (Day 1) up to Day 31
Population: Safety analysis set included all participants who received at least 1 dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-02545920 15 Milligram (mg) | Number of Participants With Laboratory Abnormalities | 18 participants |
| Placebo | Number of Participants With Laboratory Abnormalities | 8 participants |
Other Pre-specified
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 10 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.
Time frame: Baseline (Day 1) up to Day 31
Population: Safety analysis set included all participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-02545920 15 Milligram (mg) | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Adverse event | 22 participants |
| PF-02545920 15 Milligram (mg) | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Serious adverse event | 5 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Adverse event | 9 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Serious adverse event | 0 participants |
Other Pre-specified
Number of Participants With Vital Signs of Potential Clinical Concern
Criteria for vital signs of potential clinical concern: pulse rate (supine/sitting position) less than (\<) 40 or greater than (\>) 120 beats per minute (bpm), pulse rate in standing position \<40 or \>140 bpm; systolic blood pressure (SBP) \<90 millimeters of mercury (mm Hg) and greater than or equal to (\>=) 30 mm Hg change (increase, decrease) from baseline in same posture; diastolic blood pressure (DBP) \<50 mm Hg and \>=20 mm Hg change (increase, decrease) from baseline in same posture.
Time frame: Baseline (Day 1) up to Day 31
Population: Safety analysis set included all participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-02545920 15 Milligram (mg) | Number of Participants With Vital Signs of Potential Clinical Concern | Decrease from baseline in supine DBP >=20 mm Hg | 8 participants |
| PF-02545920 15 Milligram (mg) | Number of Participants With Vital Signs of Potential Clinical Concern | Supine pulse rate <40 bpm | 0 participants |
| PF-02545920 15 Milligram (mg) | Number of Participants With Vital Signs of Potential Clinical Concern | Supine pulse rate >120 bpm | 0 participants |
| PF-02545920 15 Milligram (mg) | Number of Participants With Vital Signs of Potential Clinical Concern | Standing pulse rate <40 bpm | 0 participants |
| PF-02545920 15 Milligram (mg) | Number of Participants With Vital Signs of Potential Clinical Concern | Standing pulse rate >140 bpm | 3 participants |
| PF-02545920 15 Milligram (mg) | Number of Participants With Vital Signs of Potential Clinical Concern | Supine SBP <90 mm Hg | 0 participants |
| PF-02545920 15 Milligram (mg) | Number of Participants With Vital Signs of Potential Clinical Concern | Standing SBP <90 mm Hg | 1 participants |
| PF-02545920 15 Milligram (mg) | Number of Participants With Vital Signs of Potential Clinical Concern | Increase from baseline in supine SBP >=30 mm Hg | 0 participants |
| PF-02545920 15 Milligram (mg) | Number of Participants With Vital Signs of Potential Clinical Concern | Increase from baseline in standing SBP >=30 mm Hg | 1 participants |
| PF-02545920 15 Milligram (mg) | Number of Participants With Vital Signs of Potential Clinical Concern | Decrease from baseline in supine SBP >=30 mm Hg | 3 participants |
| PF-02545920 15 Milligram (mg) | Number of Participants With Vital Signs of Potential Clinical Concern | Decrease from baseline in standing SBP >=30 mm Hg | 2 participants |
| PF-02545920 15 Milligram (mg) | Number of Participants With Vital Signs of Potential Clinical Concern | Supine DBP <50 mm Hg | 1 participants |
| PF-02545920 15 Milligram (mg) | Number of Participants With Vital Signs of Potential Clinical Concern | Standing DBP <50 mm Hg | 1 participants |
| PF-02545920 15 Milligram (mg) | Number of Participants With Vital Signs of Potential Clinical Concern | Increase from baseline in supine DBP >=20 mm Hg | 2 participants |
| PF-02545920 15 Milligram (mg) | Number of Participants With Vital Signs of Potential Clinical Concern | Increase from baseline in standing DBP >=20 mm Hg | 4 participants |
| PF-02545920 15 Milligram (mg) | Number of Participants With Vital Signs of Potential Clinical Concern | Decrease from baseline in standing DBP >=20 mm Hg | 4 participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Concern | Standing DBP <50 mm Hg | 0 participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Concern | Decrease from baseline in supine SBP >=30 mm Hg | 3 participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Concern | Increase from baseline in standing SBP >=30 mm Hg | 0 participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Concern | Supine pulse rate <40 bpm | 0 participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Concern | Decrease from baseline in supine DBP >=20 mm Hg | 2 participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Concern | Supine pulse rate >120 bpm | 0 participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Concern | Increase from baseline in supine DBP >=20 mm Hg | 0 participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Concern | Standing pulse rate <40 bpm | 0 participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Concern | Decrease from baseline in standing SBP >=30 mm Hg | 1 participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Concern | Standing pulse rate >140 bpm | 2 participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Concern | Decrease from baseline in standing DBP >=20 mm Hg | 6 participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Concern | Supine SBP <90 mm Hg | 0 participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Concern | Supine DBP <50 mm Hg | 0 participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Concern | Standing SBP <90 mm Hg | 0 participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Concern | Increase from baseline in standing DBP >=20 mm Hg | 0 participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Concern | Increase from baseline in supine SBP >=30 mm Hg | 0 participants |
Other Pre-specified
Oral Clearance (CL/F) of PF-02545920
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Time frame: Hour 0 (pre-morning dose) on Day 7, 14, 21; 20 minutes post-dose on Day 7; 1.5, 4.5 hours post-dose on Day 14 and 24 hours post-dose on Day 21
Population: Data was not collected for this outcome measure, due to early termination of the study and the limited number of participants dosed with PF-02545920 resulted in insufficient pharmacokinetic (PK) sampling to support development of a model to calculate the PK parameters.
Other Pre-specified
Steady State Average Concentration of PF-02545920 Over the Dosing Interval (Css,Avg)
Time frame: Hour 0 (pre-morning dose) on Day 7, 14, 21; 20 minutes post-dose on Day 7; 1.5, 4.5 hours post-dose on Day 14 and 24 hours post-dose on Day 21
Population: Data was not collected for this outcome measure, due to early termination of the study and the limited number of participants dosed with PF-02545920 resulted in insufficient PK sampling to support development of a model to calculate the PK parameters.