| 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Day 1), Day 21 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
| | | Title | Denominators | Categories |
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| Baseline | - ParticipantsOG00024
- ParticipantsOG00110
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| 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. | Mixed Models Analysis | | 0.86 | | Least square (LS) mean difference | -1.61 | Standard Error of the Mean | 8.94 | 2-Sided | 90 | -16.49 | 13.27 | | | | | Superiority or Other | | |
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| 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Day 1), Day 21 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Day 1), Day 21 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Day 1), Day 21 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Day 1), Day 21 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Day 1), Day 21 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Day 1), Day 21 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Day 1), Day 21 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Day 1), Day 21 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Day 1), Day 21 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Day 1), Day 21 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Day 4), Day 21 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Day 1), Day 21 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | Placebo | |
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| 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Day 1), Day 21 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | Safety analysis set included all participants who received at least 1 dose of study medication. | Posted | | Number | | participants | | Baseline (Day 1) up to Day 31 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | Safety analysis set included all participants who received at least 1 dose of study medication. | Posted | | Number | | participants | | Baseline (Day 1) up to Day 31 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | Safety analysis set included all participants who received at least 1 dose of study medication. | Posted | | Number | | participants | | Baseline (Day 1) up to Day 31 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | Safety analysis set included all participants who received at least 1 dose of study medication. | Posted | | Number | | participants | | Baseline (Day 1) up to Day 31 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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). | Safety analysis set included all participants who received at least 1 dose of study medication. | Posted | | Number | | participants | | Baseline (Day 1) up to Day 31 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | Placebo | |
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| Other Pre-specified | Number of Participants With Abnormal Prolactin Level | Number of participants with abnormal values (>1.1* ULN) of prolactin level were reported. | Safety analysis set included all participants who received at least 1 dose of study medication. | Posted | | Number | | participants | | Baseline (Day 1) up to Day 21 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | Safety analysis set included all participants who received at least 1 dose of study medication. | Posted | | Number | | participants | | Baseline up to Day 21 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Number | | participants | | Baseline (Day 1) up to Day 21 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Number | | participants | | Baseline (Day 1) up to Day 21 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Other Pre-specified | Change From Baseline in Body Weight at Day 21 | | Safety analysis set included all participants who received at least 1 dose of study medication. | Posted | | Mean | Standard Deviation | kilogram | | Baseline (Day 1), Day 21 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Other Pre-specified | Change From Baseline in Abdominal Girth at Day 21 | | Safety analysis set included all participants who received at least 1 dose of study medication. | Posted | | Mean | Standard Deviation | centimeter | | Baseline (Day 1), Day 21 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | Safety analysis set included all participants who received at least 1 dose of study medication. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Day 1), Day 21 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | Safety analysis set included all participants who received at least 1 dose of study medication. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Day 1), Day 4, 7, 14, 21 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | | | | | 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 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | | | | | 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 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Other Pre-specified | Steady State Average Concentration of PF-02545920 Over the Dosing Interval (Css,Avg) | | 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. | Posted | | | | | | 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 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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