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Trial record 46 of 66 for:    strength | ( Map: India )

Safety And Efficacy Of Ziprasidone In Adolescents With Schizophrenia

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ClinicalTrials.gov Identifier: NCT00257192
Recruitment Status : Terminated (Please see Detailed Description for termination reason.)
First Posted : November 22, 2005
Results First Posted : April 13, 2010
Last Update Posted : December 6, 2011
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Schizophrenia
Interventions Drug: placebo
Drug: Ziprasidone oral capsules
Enrollment 284
Recruitment Details A planned interim analysis resulted in recommendation from Data Safety Monitoring Board (DSMB) to terminate study due to futility per the interim analysis charter (p-value = 0.9840). Only one active subject in the study was affected by this decision.
Pre-assignment Details Screening visit followed by a 1 to 10 day period to allow for wash-out of exclusionary medications.
Arm/Group Title Ziprasidone Placebo
Hide Arm/Group Description Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study. Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Period Title: Overall Study
Started 193 91 [1]
Received Study Treatment 193 90
Completed 135 52
Not Completed 58 39
Reason Not Completed
Adverse Event             21             10
Laboratory abnormality             1             1
Lost to Follow-up             3             3
Insufficient clinical response             18             18
Withdrawal by Subject             14             2
Randomized but not treated             0             1
Study terminated by sponsor             1             0
Miscellaneous             0             4
[1]
Includes 1 subject randomized but not treated
Arm/Group Title Ziprasidone Placebo Total
Hide Arm/Group Description Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study. Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study. Total of all reporting groups
Overall Number of Baseline Participants 193 90 283
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 193 participants 90 participants 283 participants
>12 years and <13 years at start of treatment 4 0 4
Between 13 and 17 years 189 90 279
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 193 participants 90 participants 283 participants
15.3  (1.4) 15.4  (1.4) 15.3  (1.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 193 participants 90 participants 283 participants
Female
84
  43.5%
28
  31.1%
112
  39.6%
Male
109
  56.5%
62
  68.9%
171
  60.4%
Ethnicity  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 193 participants 90 participants 283 participants
Hispanic / Latino 21 9 30
Not Hispanic / Latino 172 81 253
Race  
Measure Type: Number
Unit of measure:  Particpants
Number Analyzed 193 participants 90 participants 283 participants
White 116 60 176
Black 17 2 19
Asian 38 17 55
Hispanic 9 3 12
Other 13 8 21
Tanner adolescent pubertal self-assessment: Breast (females)   [1] 
Measure Type: Number
Unit of measure:  Particpants
Number Analyzed 193 participants 90 participants 283 participants
Stage 1 0 1 1
Stage 2 6 3 9
Stage 3 16 4 20
Stage 4 35 11 46
Stage 5 25 9 34
Not applicable 109 62 171
Missing (not answered) 2 0 2
[1]
Measure Description: At baseline, subjects self-administer a gender appropriate Tanner Adolescent Pubertal Staging Questionnaire to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; males pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size).
Tanner adolescent pubertal self-assessment: Genitalia (males)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 193 participants 90 participants 283 participants
Stage 1 0 1 1
Stage 2 9 3 12
Stage 3 25 16 41
Stage 4 57 26 83
Stage 5 18 16 34
Not applicable 82 28 110
Missing (not answered) 2 0 2
[1]
Measure Description: At baseline, subjects self-administer a gender appropriate Tanner Adolescent Pubertal Staging Questionnaire to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; males pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size).
Tanner adolescent pubertal self-assessment: Pubic hair (females and males)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 193 participants 90 participants 283 participants
Stage 1 0 3 3
Stage 2 13 7 20
Stage 3 36 13 49
Stage 4 90 43 133
Stage 5 52 24 76
Missing (not answered) 2 0 2
[1]
Measure Description: At baseline, subjects self-administer a gender appropriate Tanner Adolescent Pubertal Staging Questionnaire to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; males pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size).
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters (cm)
Number Analyzed 193 participants 90 participants 283 participants
164.9  (10.1) 167.8  (10.0) 165.8  (10.1)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms (kg)
Number Analyzed 193 participants 90 participants 283 participants
61.2  (15.5) 64.3  (15.7) 62.2  (15.6)
1.Primary Outcome
Title Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total Score at Week 6
Hide Description BPRS-A: 18-item clinician rated scale to assess somatic concern, anxiety, emotional withdrawal, disorganization, hallucinatory behavior, guilt feelings, suspiciousness, disorientation, tension, mannerisms, posturing, grandiosity, depressive mood, hostility, motor retardation, uncooperativeness, unusual thought content, blunted affect, and excitement. Ratings anchored to improve consistency for a single rater over time or between raters. Items rated on 7-point scale 0 (not present) to 6 (extremely severe). Total score=sum of items (range 0 to 108); higher scores indicate increased pathology.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT): all randomized subjects who had baseline measurements, took at least 1 dose of study medication, and had at least 1 post-baseline visit. N=number of subjects with analyzable data at post-baseline observation.
Arm/Group Title Ziprasidone Placebo
Hide Arm/Group Description:
Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Overall Number of Participants Analyzed 189 87
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
-14.16  (0.78) -12.35  (1.05)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Sample size for 85% power 2-tailed 0.05 significance level based on expected difference of -5 with average within-group standard deviation=13 was 276 subjects (2 to 1 ratio of enrollment: 184 ziprasidone, 92 placebo). Interim analysis at 60 percent (%) enrollment (ITT population): may stop trial early for efficacy (2-sided p-value less than (<) 0.0124) or for futility (2-sided p-value greater than (>) 0.4772; The final analysis is to employ a 2-sided p-value <0.0462.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1530
Comments Mixed effects repeated measures (MMRM) analysis of covariance model with subject as random effect, treatment, region, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate.
Method ANCOVA
Comments P-value for final analysis is to be adjusted due to planned interim analysis (0.0462).
Method of Estimation Estimation Parameter Least squares mean
Estimated Value -1.80
Confidence Interval (2-Sided) 95%
-4.28 to 0.67
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.26
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Week 6
Hide Description CGI-S: single-item clinician rated scale to rate the severity of a subject's illness over time. Scores range from 1 (normal, not at all ill) to 7 (among the most severely ill subjects); higher score indicates more affected.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT; N=number of subjects with analyzable data at post-baseline observation.
Arm/Group Title Ziprasidone Placebo
Hide Arm/Group Description:
Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Overall Number of Participants Analyzed 190 87
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
-1.05  (0.08) -0.84  (0.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Difference from placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1289
Comments Mixed effects repeated measures (MMRM) analysis of covariance model with subject as random effect, treatment, region, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate.
Method ANCOVA
Comments Hochberg procedure was applied to p-value to preserve type I error in the analysis of key secondary endpoints (PANSS total score and CGI-S).
Method of Estimation Estimation Parameter Least squares mean
Estimated Value -0.21
Confidence Interval (2-Sided) 95%
-0.48 to 0.06
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Week 6
Hide Description PANSS: 30-item clinician-rated scale to measure severity of psychopathology (16 items); positive scale (7 items); negative scale (7 items); summarized as positive score, negative score, and total score. Items scored on anchored Likert scale rated 1 (absent symptoms) to 7 (extreme); scores above 1 indicate clinical symptom is present; scores from 2 to 7 indicate increased severity. Total score range 30 to 210: higher score indicates greater severity.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT; N=number of subjects with analyzable data at post-baseline observation.
Arm/Group Title Ziprasidone Placebo
Hide Arm/Group Description:
Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Overall Number of Participants Analyzed 183 86
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
-23.58  (1.42) -21.01  (1.73)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Total score: difference from placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1987
Comments Mixed effects repeated measures (MMRM) analysis of covariance model with subject as random effect, treatment, region, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate.
Method ANCOVA
Comments Hochberg procedure was applied to p-value to preserve type I error in the analysis of key secondary endpoints (PANSS total score and CGI-S).
Method of Estimation Estimation Parameter Least squares mean
Estimated Value -2.57
Confidence Interval 95%
-6.50 to 1.36
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.00
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in PANSS: Positive and Negative Subscales at Week 6
Hide Description PANSS: 30-item clinician-rated scale to measure severity of psychopathology (16 items); positive scale (7 items); negative scale (7 items); summarized as positive score, negative score, and total score. Items scored on anchored Likert scale rated 1 (absent symptoms) to 7 (extreme); scores above 1 indicate clinical symptom is present; scores from 2 to 7 indicate increased severity. Total score range 30 to 210: higher score indicates greater severity.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT; N=number of subjects with analyzable data at post-baseline observation.
Arm/Group Title Ziprasidone Placebo
Hide Arm/Group Description:
Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Overall Number of Participants Analyzed 183 86
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Positive score -7.22  (0.44) -5.88  (0.56)
Negative score -5.51  (0.43) -5.09  (0.51)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Positive score: difference from placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0412
Comments Mixed effects repeated measures (MMRM) analysis of covariance model with subject as random effect, treatment, region, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean
Estimated Value -1.33
Confidence Interval (2-Sided) 95%
-2.61 to -0.05
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.65
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Negative score: difference from placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4661
Comments Mixed effects repeated measures (MMRM) analysis of covariance model with subject as random effect, treatment, region, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean
Estimated Value -0.43
Confidence Interval (2-Sided) 95%
-1.57 to 0.72
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.58
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Clinical Global Impression of Improvement (CGI-I) Score at Week 6
Hide Description CGI-I: single-item clinician rated scale used to assess the subject's improvement or worsening from baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse); higher score indicates more affected.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT; N=number of subjects with analyzable data at post-baseline observation.
Arm/Group Title Ziprasidone Placebo
Hide Arm/Group Description:
Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Overall Number of Participants Analyzed 190 87
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
2.66  (0.09) 2.85  (0.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Difference from placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1820
Comments Mixed effects MMRM with subject as random effect, treatment, region, visit and visit-by-treatment interaction as fixed effects.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean
Estimated Value -0.19
Confidence Interval (2-Sided) 95%
-0.47 to 0.09
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Children's Global Assessment Scale (CGAS)
Hide Description CGAS: clinician-rated global assessment item for children based on symptoms and social functioning in home, school, and community settings. Scores on this single item range from 1 to 100 (higher levels indicate greater health) with descriptive anchors for every 10-point interval. Scores above 70 on this scale are considered within the “normal” range; lower score indicates need for increased supervision.
Time Frame Baseline, Week 2, Week 4, Week 6, Early termination (ET)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT; (n)=number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. ET includes observations from visits not within windowing criteria. Last observation carried forward [LOCF] imputation used for Week 6 LOCF timepoint.
Arm/Group Title Ziprasidone Placebo
Hide Arm/Group Description:
Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Overall Number of Participants Analyzed 193 90
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 2 (n=183, 86) 4.7  (8.7) 2.6  (5.8)
Week 4 (n=155, 63) 7.9  (10.4) 6.2  (8.9)
Week 6 (n=135, 52) 10.9  (11.8) 10.8  (9.9)
ET (n=20, 15) 1.3  (10.1) 1.7  (8.9)
Week 6 [LOCF] (n=185, 87) 8.4  (11.8) 6.4  (10.6)
7.Secondary Outcome
Title Change From Baseline in Child Health Questionnaire (CHQ)
Hide Description CHQ: 50-item, 15 subscale parent or legal guardian assessed instrument of child’s physical, emotional, social well-being, and relative burden of disease on the parents; rated on Likert-type scale: range 0 to 100; higher scores indicate a more positive health status. Global indicators for Physical Health and Psychosocial Health are weighted composites derived from subscale items using scoring algorithms (transformed scores); range 0 to 100: higher scores indicate more positive health status.
Time Frame Baseline, Week 6, ET
Hide Outcome Measure Data
Hide Analysis Population Description
ITT. ET includes observations from visits not within windowing criteria. LOCF imputation used for Week 6 LOCF timepoint.
Arm/Group Title Ziprasidone Placebo
Hide Arm/Group Description:
Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Overall Number of Participants Analyzed 193 90
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Global health: Week 6 5.0  (18.2) 8.5  (24.7)
Global health: ET -5.4  (24.0) -9.1  (17.4)
Global health: Week 6 [LOCF] 2.8  (19.9) 1.4  (23.7)
Global behavior: Week 6 9.4  (23.6) 10.9  (22.1)
Global behavior: ET 6.4  (21.4) -0.5  (23.0)
Global behavior: Week 6 [LOCF] 8.8  (23.1) 6.5  (23.1)
Family cohesion: Week 6 1.9  (21.3) -0.8  (19.7)
Family cohesion: ET -1.8  (18.4) -2.6  (16.1)
Family cohesion: Week 6 [LOCF] 1.2  (20.8) -1.1  (18.1)
Physical health: Week 6 3.5  (33.9) 5.0  (28.0)
Physical health: ET -6.5  (32.9) 3.2  (23.3)
Physical health: Week 6 [LOCF] 1.4  (33.8) 4.8  (26.0)
Bodily pain: Week 6 4.4  (21.6) 8.0  (19.4)
Bodily pain: ET 4.7  (23.0) 0.0  (14.6)
Bodily pain: Week 6 [LOCF] 4.5  (21.9) 4.9  (18.1)
Emotion, behavior: Week 6 16.2  (29.8) 13.8  (31.1)
Emotion, behavior: ET 4.0  (43.1) -2.5  (22.7)
Emotion, behavior: Week 6 [LOCF] 13.6  (33.4) 7.8  (29.2)
Time impact on parent: Week 6 8.8  (25.4) 11.8  (23.1)
Time impact on parent: ET 2.0  (25.8) 1.8  (21.7)
Time impact on parent: Week 6 [LOCF] 7.4  (25.5) 8.0  (23.1)
Emotional impact on parent: Week 6 8.9  (21.6) 10.0  (22.3)
Emotional impact on parent: ET 3.5  (21.2) 2.7  (12.6)
Emotional impact on parent: Week 6 [LOCF] 7.7  (21.6) 7.4  (19.4)
Mental health: Week 6 8.1  (15.3) 12.6  (18.2)
Mental health: ET 1.3  (17.9) -0.8  (12.0)
Mental health: Week 6 [LOCF] 6.7  (16.1) 7.5  (17.4)
Physical function: Week 6 5.6  (19.7) 5.9  (25.2)
Physical function: ET -5.4  (22.5) -0.2  (17.7)
Physical function: Week 6 [LOCF] 3.3  (20.8) 3.7  (22.8)
Behavior scale: Week 6 9.0  (17.1) 9.0  (16.8)
Behavior scale: ET 7.6  (15.2) 0.6  (17.1)
Behavior scale: Week 6 [LOCF] 8.7  (16.7) 5.8  (17.4)
Self-esteem: Week 6 6.0  (17.5) 9.0  (22.9)
Self-esteem: ET 1.0  (20.6) 1.3  (14.0)
Self-esteem: Week 6 [LOCF] 5.0  (18.2) 6.4  (20.2)
General health perception: Week 6 1.1  (11.6) 3.3  (11.7)
General health perception: ET -2.2  (12.3) -0.6  (10.8)
General health perception: Week 6 [LOCF] 0.4  (11.8) 1.8  (11.5)
Family activities: Week 6 9.2  (22.6) 14.6  (22.5)
Family activities: ET 1.3  (16.8) -4.6  (16.5)
Family activities: Week 6 [LOCF] 7.5  (21.7) 7.8  (22.0)
Change in health: Week 6 0.5  (1.1) 0.6  (1.0)
Change in health: ET -0.4  (1.0) -0.1  (0.8)
Change in health: Week 6 [LOCF] 0.3  (1.1) 0.3  (1.0)
Physical health global subscale: Week 6 1.8  (9.7) 2.4  (9.8)
Physical health global subscale: ET -2.8  (11.8) 0.1  (4.4)
Physical health global subscale: Week 6 [LOCF] 0.9  (10.3) 1.6  (8.2)
Psychosocial health global subscale: Week 6 6.6  (9.5) 7.7  (11.0)
Psychosocial health global subscale: ET 3.1  (10.4) 0.0  (5.7)
Psychosocial health global subscale: Week 6 [LOCF] 5.9  (9.8) 4.8  (10.0)
8.Secondary Outcome
Title Change From Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) Total Score
Hide Description CPBAQ: 19-item parent or legal guardian completed questionnaire to rate the child's verbal (such as yelling or cursing) and physical aggression (such a fighting with peers or being cruel to an animal) during the past week. Behavior was rated on a 4-point scale; range 0 (behavior did not occur or was not a problem) to 3 (behavior occurred a lot or was severe problem). Total score range 0 to 57; higher scores indicate a greater frequency and severity of aggression.
Time Frame Baseline, Week 1 through Week 6
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ITT; N=number of subjects with analyzable data at baseline; (n)= number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. LOCF imputation used for Week 6 LOCF timepoint.
Arm/Group Title Ziprasidone Placebo
Hide Arm/Group Description:
Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Overall Number of Participants Analyzed 173 74
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 1 (n=165, 69) -2.4  (7.1) -1.3  (5.8)
Week 2 (n=161, 71) -2.5  (8.0) -1.0  (6.2)
Week 3 (n=146, 64) -3.0  (6.7) -0.7  (5.7)
Week 4 (n=138, 51) -2.7  (7.4) -1.0  (6.5)
Week 5 (n=126, 44) -3.1  (7.0) -0.8  (8.3)
Week 6 (n=119, 42) -3.0  (7.4) -1.9  (6.7)
Week 6 [LOCF] (n=167, 71) -2.3  (8.2) -0.3  (8.8)
9.Secondary Outcome
Title Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score
Hide Description CDRS-R: clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment.
Time Frame Baseline, Week 1 through Week 6
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ITT; N=number of subjects with analyzable data at baseline; (n)=number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. LOCF imputation used for Week 6 LOCF timepoint.
Arm/Group Title Ziprasidone Placebo
Hide Arm/Group Description:
Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Overall Number of Participants Analyzed 180 84
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 1 (n=179, 82) -2.8  (6.6) -1.4  (5.7)
Week 2 (n=174, 80) -4.2  (7.3) -2.5  (5.6)
Week 3 (n=157, 69) -5.5  (7.4) -3.2  (5.4)
Week 4 (n=148, 59) -6.0  (7.6) -4.9  (6.6)
Week 5 (n=135, 49) -7.0  (8.5) -5.6  (5.9)
Week 6 (n=126, 47) -7.9  (7.9) -6.5  (5.5)
Week 6 [LOCF] (n=178, 82) -5.8  (8.7) -4.0  (7.3)
10.Secondary Outcome
Title Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Suicide Ideation Item 13
Hide Description CDRS-R: clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Suicide Ideation (Item 13) detects changes in suicidality over time. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment).
Time Frame Baseline, Week 1 through Week 6
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ITT; N=number of subjects with analyzable data at baseline; (n)=number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. LOCF imputation used for Week 6 LOCF timepoint.
Arm/Group Title Ziprasidone Placebo
Hide Arm/Group Description:
Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Overall Number of Participants Analyzed 192 90
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 1 (n=188, 86) -0.1  (0.4) -0.0  (0.5)
Week 2 (n=182, 86) -0.0  (0.5) -0.1  (0.5)
Week 3 (n=165, 74) -0.1  (0.5) -0.1  (0.3)
Week 4 (n=154, 63) 0.0  (0.5) -0.1  (0.5)
Week 5 (n=141, 54) 0.0  (0.4) -0.1  (0.5)
Week 6 (n=134, 52) -0.0  (0.3) -0.1  (0.4)
Week 6 [LOCF] (n=189, 87) 0.0  (0.6) -0.0  (0.5)
11.Secondary Outcome
Title Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Impaired Schoolwork Item 1
Hide Description Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses resolved by using most impaired rating given by valid informant. Impaired Schoolwork (Item 1) assesses school function for the subgroup of subjects reported to be in school. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment).
Time Frame Baseline, Week 2, Week 6
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Hide Analysis Population Description
ITT; N=number of subjects with analyzable data at baseline; (n)=number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. LOCF imputation used for Week 6 LOCF timepoint.
Arm/Group Title Ziprasidone Placebo
Hide Arm/Group Description:
Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Overall Number of Participants Analyzed 40 15
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 2 (n=38, 15) -0.3  (0.9) -0.2  (0.7)
Week 6 (n=30, 8) -0.6  (1.1) -0.1  (1.4)
Week 6 [LOCF] (n=39, 15) -0.6  (1.0) -0.1  (1.1)
12.Secondary Outcome
Title Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales
Hide Description A computerized subject-administered test battery with subtests for verbal and visual memory, processing speed, nonverbal reasoning, executive functioning, working memory, and sustained attention. A computerized 7-point sedation item (0 [not sleepy] to 10 [very sleepy]) was completed prior to test battery. The Neurocognitive index score was derived from subtest scores per an algorithm. The index score and subtest scores assessed the subject’s changes in cognition. Scores were rated as above average (score >109), average (90 to 109), below average (80 to 89), or well below average (70 to 79).
Time Frame Baseline, Week 6, ET
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Hide Analysis Population Description
ITT; N=number of subjects with analyzable data at baseline; (n)= number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. ET includes observations from visits not within windowing criteria. LOCF imputation used for Week 6 LOCF timepoint (last post-baseline non-missing visit).
Arm/Group Title Ziprasidone Placebo
Hide Arm/Group Description:
Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Overall Number of Participants Analyzed 174 83
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Sedation: Week 6 (n=124, 47) 0.0  (1.7) -0.4  (1.8)
Sedation: ET (n=23, 26) 0.0  (2.3) 0.2  (1.3)
Sedation: Week 6 [LOCF] (n=147, 72) 0.0  (1.8) -0.2  (1.7)
Verbal Memory: Week 6 (n=124, 47) 1.3  (12.1) 0.5  (14.0)
Verbal Memory: ET (n=24, 25) -2.3  (13.9) -2.6  (15.1)
Verbal Memory: Week 6 [LOCF] (n=148, 71) 0.7  (12.4) -0.5  (14.4)
Visual Memory: Week 6 (n=124, 46) 0.5  (13.3) 2.0  (14.5)
Visual Memory: ET (n=24, 26) -3.8  (10.2) 0.4  (14.2)
Visual Memory: Week 6 [LOCF] (n=148, 71) -0.2  (12.9) 1.2  (14.3)
Processing Speed: Week 6 (n=124, 46) 1.3  (13.5) 1.0  (12.0)
Processing Speed: ET (n=24, 25) -10.6  (34.5) 0.5  (5.4)
Processing Speed: Week 6 [LOCF] (n=148, 70) -0.6  (18.9) 0.6  (10.1)
Reasoning: Week 6 (n=122, 46) 2.2  (12.0) -0.7  (14.6)
Reasoning: ET (n=23, 25) 1.3  (15.8) 3.3  (14.0)
Reasoning: Week 6 [LOCF] (n=145, 70) 1.9  (12.7) 0.7  (14.1)
Executive Functioning: Week 6 (n=123, 46) 2.9  (15.4) 2.7  (18.2)
Executive Functioning: ET (n=23, 26) -6.7  (9.1) 4.6  (13.2)
Executive Functioning: Week 6 [LOCF] (n=146, 71) 1.4  (14.9) 3.2  (16.6)
Working Memory: Week 6 (n=120, 45) 1.9  (12.9) 0.5  (12.9)
Working Memory: ET (n=23, 24) 3.2  (13.5) 3.7  (11.0)
Working Memory: Week 6 [LOCF] (n=143, 68) 2.0  (12.9) 1.3  (12.2)
Sustained Attention: Week 6 (n=120, 45) 2.0  (12.3) -1.6  (13.1)
Sustained Attention: ET (n=23, 24) 0.5  (13.5) 1.5  (11.6)
Sustained Attention: Week 6 [LOCF] (n=143, 68) 1.7  (12.4) -0.9  (12.6)
13.Secondary Outcome
Title Change From Baseline in CNS Vital Signs Cognitive Test Battery: Neurocognitive Index
Hide Description A computerized subject-administered test battery with subtests for verbal and visual memory, processing speed, nonverbal reasoning, executive functioning, working memory, and sustained attention. A computerized 7-point sedation item (0 [not sleepy] to 10 [very sleepy]) was completed prior to test battery. The Neurocognitive index score was derived from subtest scores per an algorithm. The index score and subtest scores assessed the subject’s changes in cognition. Scores were rated as above average (score >109), average (90 to 109), below average (80 to 89), or well below average (70 to 79).
Time Frame Baseline, Week 6, ET
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Hide Analysis Population Description
ITT; N=number of subjects with analyzable data at baseline; (n)= number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. ET includes observations from visits not within windowing criteria. LOCF imputation used for Week 6 LOCF timepoint (last post-baseline non-missing visit).
Arm/Group Title Ziprasidone Placebo
Hide Arm/Group Description:
Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Overall Number of Participants Analyzed 168 79
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Neurocognitive Index: Week 6 (n=120, 45) 1.8  (7.1) 0.8  (7.5)
Neurocognitive Index: ET (n=23, 23) -2.7  (7.6) 2.2  (7.2)
Neurocognitive Index: Week 6 [LOCF] (n=143, 67) 1.0  (7.4) 1.1  (7.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Neurocognitive Index score at Week 6: difference from placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2613
Comments SAS PROC MIXED to fit a mixed model analysis of covariance with treatment and region as fixed effects and baseline score as covariate.
Method ANCOVA
Comments Observed cases at Week 6.
Method of Estimation Estimation Parameter Least squares mean
Estimated Value 1.34
Confidence Interval (2-Sided) 95%
-1.01 to 3.69
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.19
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Change From Baseline in Movement Disorder Scales: Simpson-Angus Rating Scale (SARS)
Hide Description SARS: 10-item clinician rated instrument to assess parkinsonian symptoms (7 items) and related extrapyramidal side effects (3 items): gait, arm dropping, shoulder shaking, elbow rigidity, leg pendulousness, glabellar tap, tremor, and salivation. Head dropping (modified SARS item 7) substituted for head rotation. Anchored 5-point scale: range 0 (absence of condition, normal) to 4 (most extreme form of condition). Total score is sum of individual item scores (range 0 to 40); higher score indicates more affected.
Time Frame Baseline, Week 1 through Week 6
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Hide Analysis Population Description
ITT; N=number of subjects with analyzable data at baseline; (n)= number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. LOCF imputation used for Week 6 LOCF timepoint.
Arm/Group Title Ziprasidone Placebo
Hide Arm/Group Description:
Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Overall Number of Participants Analyzed 189 87
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 1 (n=189, 85) 0.5  (2.8) 0.1  (0.9)
Week 2 (n=182, 85) 0.5  (2.4) -0.0  (0.5)
Week 3 (n=165, 74) 0.7  (3.1) 0.3  (1.6)
Week 4 (n=154, 62) 0.4  (2.6) -0.0  (0.6)
Week 5 (n=141, 54) 0.2  (2.4) -0.0  (1.0)
Week 6 (n=134, 52) 0.2  (2.5) -0.2  (0.8)
Week 6 [LOCF] (n=189, 86) 0.3  (2.5) -0.1  (0.6)
15.Secondary Outcome
Title Change From Baseline in Movement Disorder Scales: Barnes Akathisia Rating Scale (BAS) Global Clinical Assessment Item
Hide Description BAS: clinician rated scale to assess akathisia to determine the degree of subjective restlessness and distress associated with restlessness. First 3 items (Objective, Subjective, and Distress related to restlessness) rated on a 4-point scale with range 0 (no symptoms) to 3 (increased severity of symptoms). Item 4 Global Clinical Assessment of Akathisia rated on a 6-point scale range 0 (no symptoms) to 5 (increased severity of symptoms); higher score indicates increased severity. All rating are anchored. Only the Global Clinical Assessment of Akathisia was to be analyzed.
Time Frame Baseline, Week 1 through Week 6
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Hide Analysis Population Description
ITT; N=number of subjects with analyzable data at baseline; (n)= number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. LOCF imputation used for Week 6 LOCF timepoint.
Arm/Group Title Ziprasidone Placebo
Hide Arm/Group Description:
Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Overall Number of Participants Analyzed 190 88
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 1 (n=190, 86) 0.1  (0.6) 0.1  (0.4)
Week 2 (n=183, 86) 0.1  (0.7) 0.0  (0.3)
Week 3 (n=166, 74) 0.1  (0.6) 0.0  (0.3)
Week 4 (n=155, 63) 0.1  (0.6) -0.0  (0.2)
Week 5 (n=142, 54) 0.1  (0.5) 0.0  (0.2)
Week 6 (n=135, 52) 0.0  (0.5) 0.0  (0.2)
Week 6 [LOCF] (n=190, 87) 0.0  (0.6) 0.0  (0.2)
16.Secondary Outcome
Title Change From Baseline in Movement Disorder Scales: Abnormal Involuntary Movement Scale (AIMS) Movement Cluster Score
Hide Description AIMS: clinician rated 12-item scale to rate 7 body areas and global judgments on the severity of abnormal movements, incapacitation and subject's awareness of abnormal movements. Items 1 to 10 scored 0 (none) to 4 (severe) (total possible score 0 to 40; higher score indicates greater severity); items 11 to 14 are No or Yes response to dental status and sleep movements. Only the sum of the first 7 items to be analyzed (AIMS Movement Cluster score). Total score 0 to 28; higher score indicates greater severity.
Time Frame Baseline, Week 1 through Week 6
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Hide Analysis Population Description
ITT; N=number of subjects with analyzable data at baseline; (n)=number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. LOCF imputation used for Week 6 LOCF timepoint.
Arm/Group Title Ziprasidone Placebo
Hide Arm/Group Description:
Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Overall Number of Participants Analyzed 190 88
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 1 (n=190, 86) 0.2  (1.6) -0.0  (0.4)
Week 2 (n=183, 86) 0.1  (1.6) 0.0  (0.6)
Week 3 (n=166, 74) 0.1  (1.3) 0.1  (1.0)
Week 4 (n=155, 63) 0.1  (0.8) -0.0  (0.8)
Week 5 (n=142, 54) -0.1  (0.7) 0.0  (0.4)
Week 6 (n=135, 52) 0.0  (0.6) 0.0  (0.5)
Week 6 [LOCF] (n=190, 87) 0.0  (0.8) -0.0  (0.7)
17.Secondary Outcome
Title Number of Subjects Per Response on the School Placement Questionnaire: School Situation
Hide Description School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school.
Time Frame Baseline, Week 2, Week 6, ET
Hide Outcome Measure Data
Hide Analysis Population Description
ITT; N=number of subjects analyzable for School Placement Questionnaire; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively. ET includes observations from visits not within windowing criteria. LOCF imputation used for Week 6 LOCF timepoint.
Arm/Group Title Ziprasidone Placebo
Hide Arm/Group Description:
Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Overall Number of Participants Analyzed 189 87
Measure Type: Number
Unit of Measure: participants
Baseline: Enrolled or attend (n=185, 85) 40 15
Baseline: Not attend or mental illness (n=185, 85) 62 26
Baseline: Not attend or other (n=185, 85) 2 0
Baseline: Enrolled or vacation (n=185, 85) 20 19
Baseline: Not enrolled or mental illness 36 12
Baseline: Not enrolled or other (n=185, 85) 25 13
Week 2: Enrolled or attend (n=179, 84) 38 20
Week 2: Not attend or mental illness (n=179, 84) 59 24
Week 2: Not attend or other (n=179, 84) 3 2
Week 2: Enrolled or vacation (n=179, 84) 20 11
Week 2: Not enrolled or mental illness (n=179, 84) 36 15
Week 2: Not enrolled or other (n=179, 84) 23 12
Week 6: Enrolled or attend (n=134, 51) 38 18
Week 6: Not attend or mental illness (n=134, 51) 36 7
Week 6: Not attend or other (n=134, 51) 3 0
Week 6: Enrolled or vacation (n=134, 51) 14 5
Week 6: Not enrolled or mental illness (n=134, 51) 23 11
Week 6: Not enrolled or other (n=134, 51) 20 10
ET: Enrolled or attend (n=32, 25) 5 3
ET: Not attend or mental illness (n=32, 25) 8 14
ET: Not attend or other (n=32, 25) 0 0
ET: Enrolled or vacation (n=32, 25) 5 4
ET: Not enrolled or mental illness (n=32, 25) 10 3
ET: Not enrolled or other (n=32, 25) 4 1
Week 6 [LOCF]: Enrolled or attend (n=183, 86) 47 23
Week 6 [LOCF]: Not attend or mental illness 50 86
Week 6 [LOCF]: Not attend or other (n=183, 86) 3 1
Week 6 [LOCF]: Enrolled or vacation (n=183, 86) 21 10
Week 6 [LOCF]: Not enrolled or mental illness 36 17
Week 6 [LOCF]: Not enrolled or other (n=183, 86) 26 12
18.Secondary Outcome
Title Number of Subjects Per Response on the School Placement Questionnaire: School Attendance
Hide Description School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school.
Time Frame Baseline, Week 2, Week 6, ET
Hide Outcome Measure Data
Hide Analysis Population Description
ITT; N=number of subjects analyzable for School Placement Questionnaire; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively. ET includes observations from visits not within windowing criteria. LOCF imputation used for Week 6 LOCF timepoint.
Arm/Group Title Ziprasidone Placebo
Hide Arm/Group Description:
Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Overall Number of Participants Analyzed 189 87
Measure Type: Number
Unit of Measure: participants
Baseline: No absences (n=88, 42) 20 7
Baseline: Only a few absences (n=88, 42) 16 15
Baseline: Frequent absences (n=88, 42) 13 2
Baseline: Did not attend (n=88, 42) 26 7
Baseline: Not applicable or vacation (n=88, 42) 13 11
Week 2: No absences (n=82, 36) 19 8
Week 2: Only a few absences (n=82, 36) 14 9
Week 2: Frequent absences (n=82, 36) 11 4
Week 2: Did not attend (n=82, 36) 25 8
Week 2: Not applicable or vacation (n=82, 36) 13 7
Week 6: No absences (n=67, 24) 16 8
Week 6: Only a few absences (n=67, 24) 22 12
Week 6: Frequent absences (n=67, 24) 5 0
Week 6: Did not attend (n=67, 24) 13 0
Week 6: Not applicable or vacation (n=67, 24) 11 4
ET: No absences (n=12, 12) 1 0
ET: Only a few absences (n=12, 12) 4 0
ET: Frequent absences (n=12, 12) 2 5
ET: Did not attend (n=12, 12) 4 4
ET: Not applicable or vacation (n=12, 12) 1 3
Week 6 [LOCF]: No absences (n=89, 37) 18 8
Week 6 [LOCF]: Only a few absences (n=89, 37) 26 13
Week 6 [LOCF]: Frequent absences (n=89, 37) 11 4
Week 6 [LOCF]: Did not attend (n=89, 37) 21 4
Week 6[LOCF]: Not applicable or vacation(n=89,37) 13 8
19.Secondary Outcome
Title Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance
Hide Description School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school.
Time Frame Baseline, Week 2, Week 6, ET
Hide Outcome Measure Data
Hide Analysis Population Description
ITT; N=number of subjects analyzable for School Placement Questionnaire; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively. ET includes observations from visits not within windowing criteria. LOCF imputation used for Week 6 LOCF timepoint.
Arm/Group Title Ziprasidone Placebo
Hide Arm/Group Description:
Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Overall Number of Participants Analyzed 189 87
Measure Type: Number
Unit of Measure: participants
Baseline: Excellent (n=64, 29) 4 2
Baseline: Good (n=64, 29) 10 6
Baseline: Fair (n=64, 29) 25 14
Baseline: Poor (n=64, 29) 19 3
Baseline: Very poor (n=64, 29) 6 4
Week 2: Excellent (n=60, 26) 5 1
Week 2: Good (n=60, 26) 12 8
Week 2: Fair (n=60, 26) 20 10
Week 2: Poor (n=60, 26) 17 5
Week 2: Very poor (n=60, 26) 6 2
Week 6: Excellent (n=52, 21) 4 1
Week 6: Good (n=52, 21) 16 8
Week 6: Fair (n=52, 21) 17 11
Week 6: Poor (n=52, 21) 12 1
Week 6: Very poor (n=52, 21) 3 0
ET: Excellent (n=8, 7) 0 0
ET: Good (n=8, 7) 0 1
ET: Fair (n=8, 7) 5 3
ET: Poor (n=8, 7) 2 1
ET: Very poor (n=8, 7) 1 2
Week 6 [LOCF]: Excellent (n=68, 28) 4 1
Week 6 [LOCF]: Good (n=68, 28) 18 9
Week 6 [LOCF]: Fair (n=68, 28) 24 14
Week 6 [LOCF]: Poor (n=68, 28) 16 2
Week 6 [LOCF]: Very poor (n=68, 28) 6 2
Time Frame Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Adverse Event Reporting Description Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
 
Arm/Group Title Ziprasidone Placebo
Hide Arm/Group Description Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study. Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
All-Cause Mortality
Ziprasidone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ziprasidone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   9/193 (4.66%)   1/90 (1.11%) 
Injury, poisoning and procedural complications     
Overdose  1  1/193 (0.52%)  0/90 (0.00%) 
Skin laceration  1  1/193 (0.52%)  0/90 (0.00%) 
Psychiatric disorders     
Aggression  1  0/193 (0.00%)  1/90 (1.11%) 
Anxiety  1  1/193 (0.52%)  0/90 (0.00%) 
Depression  1  1/193 (0.52%)  0/90 (0.00%) 
Hallucination, auditory  1  1/193 (0.52%)  0/90 (0.00%) 
Hostility  1  1/193 (0.52%)  0/90 (0.00%) 
Impulsive behaviour  1  1/193 (0.52%)  0/90 (0.00%) 
Psychotic disorder  1  0/193 (0.00%)  1/90 (1.11%) 
Schizophrenia  1  2/193 (1.04%)  0/90 (0.00%) 
Suicidal ideation  1  2/193 (1.04%)  0/90 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ziprasidone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   110/193 (56.99%)   27/90 (30.00%) 
Gastrointestinal disorders     
Nausea  1  19/193 (9.84%)  2/90 (2.22%) 
Vomiting  1  12/193 (6.22%)  3/90 (3.33%) 
General disorders     
Fatigue  1  17/193 (8.81%)  4/90 (4.44%) 
Injury, poisoning and procedural complications     
Overdose  1 [1]  11/193 (5.70%)  4/90 (4.44%) 
Nervous system disorders     
Akathisia  1  13/193 (6.74%)  3/90 (3.33%) 
Dizziness  1  18/193 (9.33%)  1/90 (1.11%) 
Extrapyramidal disorder  1  22/193 (11.40%)  1/90 (1.11%) 
Headache  1  15/193 (7.77%)  2/90 (2.22%) 
Somnolence  1  38/193 (19.69%)  6/90 (6.67%) 
Tremor  1  15/193 (7.77%)  1/90 (1.11%) 
Psychiatric disorders     
Insomnia  1  18/193 (9.33%)  13/90 (14.44%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.0)
[1]
All overdoses were due to clinical or subject error.
The AE tables were amended to incorporate previously unreported AEs that were found during an independent audit and verified by the investigators.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
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Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.govCallCenter@pfizer.com
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00257192     History of Changes
Other Study ID Numbers: A1281134
First Submitted: November 21, 2005
First Posted: November 22, 2005
Results First Submitted: March 23, 2010
Results First Posted: April 13, 2010
Last Update Posted: December 6, 2011