| Primary | Young Mania Rating Scale (YMRS) Total Score Change From Baseline | YMRS: 11-item instrument with scales 0 (normal) to 4 (highest abnormal)for 7 items and 0 (normal) to 8 (highest abnormal) for 4 items. Total possible 0 - 60. Baseline is from parent study A1281132. | The Safety Analysis Set includes all subjects who took at least one dose of study medication in this open-label extension study. (Row: n=number subjects with observation) | Posted | | Mean | Standard Deviation | score on scale | | baseline and 26 Weeks; 26 Weeks Last Observation Carried Forward (LOCF) | | | | ID | Title | Description |
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| OG000 | Ziprasidone | Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). |
| | | Title | Denominators | Categories |
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| Week 2 (n=153) | | | | Week 6 (n=122) | | | | Week 18 (n=76) | | |
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| Primary | Clinical Global Impression of Severity (CGI-S) Change From Baseline | CGI-S Scale:standardized assessment tool to rate severity of subject's illness; assesses investigator's impression of subject's current illness state. Change: score at observation minus score at baseline. Score: 1 (not ill at all) to 7 (among most extremely ill). Baseline = last available observation from parent double-blind study(A1281132). | The Safety Analysis Set includes all subjects who took at least one dose of study medication in this open-label extension study. (Row: n=number subjects with observation) | Posted | | Mean | Standard Deviation | score on scale | | baseline and 26 Weeks; 26 Weeks LOCF | | | | ID | Title | Description |
|---|
| OG000 | Ziprasidone | Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). |
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| Primary | Incidence of Lab Abnormalities | number of subjects with an abnormal lab value for those parameters with 5% or greater incidence of abnormality. | Total number of subjects with given laboratory test at given visit. Range: N=136-134, with the exception of Insulin (N=115) | Posted | | Number | | participants | | Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Ziprasidone | Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). |
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| Primary | Change in Low-Density Lipoprotein (LDL) Cholesterol and Fasting Cholesterol | Mean Change: lab value at observation minus lab value at baseline. | The Safety Analysis Set includes all subjects who took at least one dose of study medication in this open-label extension study. (Row: n= total number of subjects with at least 1 observation of the given laboratory test.) | Posted | | Mean | Standard Deviation | milligram /deciliter (mg/dL) | | Week 6, Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Ziprasidone | Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). |
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| Primary | Change in Hormones | Mean Change: lab value at observation minus lab value at baseline | The Safety Analysis Set includes all subjects who took at least one dose of study medication in this open-label extension study. (Row: n= total number of subjects with at least 1 observation of the given laboratory test.) | Posted | | Mean | Standard Deviation | nanogram/deciliter (ng/dL) | | Week 6, Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Ziprasidone | Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). |
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| Primary | Mean Change From Baseline in Supine Systolic Blood Pressure | Mean Change: vital sign value at observation minus vital sign value at baseline | | Posted | | Mean | Standard Deviation | millimeters of mercury (mm Hg) | | Week 1 through Week 26 | | | | ID | Title | Description |
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| OG000 | Ziprasidone | Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). |
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| Primary | Mean Change From Baseline in Supine Diastolic Blood Pressure | Mean Change: vital sign value at observation minus vital sign value at baseline | | Posted | | Mean | Standard Deviation | millimeters mercury (mm Hg) | | Week 1 through Week 26 | | | | ID | Title | Description |
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| OG000 | Ziprasidone | Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). |
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| Primary | Mean Change From Baseline in Supine Pulse Rates | Mean Change: vital sign value at observation minus vital sign value at baseline | | Posted | | Mean | Standard Deviation | beats per minute | | Week 1 through Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Ziprasidone | Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). |
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| Primary | Mean Change From Baseline in Standing Systolic Blood Pressure | Mean Change: vital sign value at observation minus vital sign value at baseline | | Posted | | Mean | Standard Deviation | mm Hg | | Week 1 through Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Ziprasidone | Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). |
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| Primary | Mean Change From Baseline in Standing Diastolic Blood Pressure | Mean Change: vital sign value at observation minus vital sign value at baseline | | Posted | | Mean | Standard Deviation | mm Hg | | Week 1 through Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Ziprasidone | Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). |
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| Primary | Mean Change From Baseline in Standing Pulse Rates | Mean Change: vital sign value at observation minus vital sign value at baseline | | Posted | | Mean | Standard Deviation | beats per minute | | Week 1 through Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Ziprasidone | Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). |
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| Primary | Mean Change From Baseline for Body Weight | Mean change; body weight value at observation minus body weight value at baseline. | | Posted | | Mean | Standard Deviation | kilogram | | Week 6, Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Ziprasidone | Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). |
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| Primary | Mean Change From Baseline for Body Mass Index (BMI) Z-Score | mean change in body weight BMI -Z score calculated by subtracting median reference value of the population from observed value and dividing by standard deviation of reference population (kg/m squared). 0=no change | | Posted | | Mean | Standard Deviation | score on scale | | Week 6, 26, early termination | | | | ID | Title | Description |
|---|
| OG000 | Ziprasidone | Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). |
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| Primary | Body Mass Index (BMI) Z-score Frequency | change in body weight BMI -Z score calculated by subtracting median reference value of the population from observed value and dividing by standard deviation of reference population (kg/m squared). 0=no change | | Posted | Feb 2009 | Number | | participants | | Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Ziprasidone | Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). |
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| Primary | Body Mass Index (BMI) Z-score Frequency | change in body weight BMI -Z score calculated by subtracting median reference value of the population from observed value and dividing by standard deviation of reference population (kg/m squared). 0=no change | | Posted | Feb 2009 | Number | | participants | | Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Ziprasidone | Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). |
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| Primary | Mean Change From Baseline for QTcF Intervals | QT intervals (observed in an electrocardiogram)corrected using Fridericia's formula (QTcF). Mean change: mean change of observation minus baseline. Baseline: last available observation in the parent double-blind study. | | Posted | | Mean | Standard Deviation | millisecond | | Baseline to Week 26 (end of study) | | | | ID | Title | Description |
|---|
| OG000 | Ziprasidone | Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). |
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| Primary | Frequency of Largest Categorical Increases in QTcF for Males | QT intervals (observed in an electrocardiogram) corrected with Fridericia's Formula (QTcF). Number of subjects with corresponding categorical increase in QTcF. | | Posted | | Number | | participants | | Week 26 (end of study) | | | | ID | Title | Description |
|---|
| OG000 | Ziprasidone | Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). |
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| Primary | Frequency of Largest Categorical Increases in QTcF for Females | QT interval (observed in an electrocardiogram) corrected using Fridericia Formula (QTcF). Number of subjects with corresponding categorical increase in QTcF. | | Posted | | Number | | participants | | Week 26 (end of study) | | | | ID | Title | Description |
|---|
| OG000 | Ziprasidone | Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). |
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| Primary | Frequency of Largest Categorical Increases in QTcF - All Subjects | QT intervals (observed in an electrocardiogram)corrected using Fridericia Formula (QTcF). Number of subjects with corresponding categorical increase in QTcF. | | Posted | | Number | | participants | | Week 26 (end of study) | | | | ID | Title | Description |
|---|
| OG000 | Ziprasidone | Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). |
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