40 Week Extension Study Of Asenapine and Olanzapine For Bipolar Disorder (A7501007)(COMPLETED)(P05857)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Double-Blind, 40-Week Continuation Study Evaluating the Safety of Asenapine and Olanzapine in the Treatment of Subjects With Acute Mania Clinical Trial Protocol A7501007 (Secondary Title: ARES)|
- Participants Who Experienced Adverse Event(s) [ Time Frame: Up to 40 weeks ] [ Designated as safety issue: Yes ]
Adverse event (AE) data, both serious and non-serious, were collected. Serious AEs were also collected up to 30 days post last dose of study drug.
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product. It does not necessarily have to have a causal relationship with this treatment.
An AE is defined as serious if it results in death, is life-threatening, requires in-patient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
- Number of Participants With Abnormal Physical Examination Findings [ Time Frame: Week 40 or endpoint ] [ Designated as safety issue: Yes ]Physical exam (PE) included assessment of general appearance, skin, head, eyes, ears, nose, throat, lungs, blood pressure, cardiac rhythm & rate, neurologic status, and abdomen. The findings were deemed to be normal/abnormal based on the clinical judgment of the investigator.
- Number of Participants With Abnormal Electrocardiogram [ Time Frame: Week 40 or endpoint ] [ Designated as safety issue: Yes ]This is the number of participants with electrocardiogram (ECG) adverse events.
- Body Weight [ Time Frame: Baseline to Week 40 or endpoint ] [ Designated as safety issue: Yes ]Weight change from baseline
- Extrapyramidal Symptoms [EPS] [ Time Frame: Week 40 or endpoint ] [ Designated as safety issue: Yes ]
EPS was assessed using the (1) involuntary movement scale [AIMS], (2) Barnes Akathisia Rating Scale [BARS], and (3) Simpson Angus Rating Scale SARS.
AIMS score range 0-4; higher scores indicate greater symptom severity.
BARS score rang 0-9; higher scores indicate greater severity of akathisia.
SARS score range 0-40; higher scores indicate greater degree of Parkinsonism.
- Concomitant Medications [ Time Frame: Up to 40 weeks ] [ Designated as safety issue: Yes ]
Concomitant medications are any medications taken on or after the date of first dose of double-blind study drug through the date of
last dose of double-blind study drug.
- Abdominal Girth [ Time Frame: Baseline to Week 40 or endpoint ] [ Designated as safety issue: Yes ]Change in abdominal girth from baseline
- Number of Participants With Markedly Abnormal Vital Sign Changes [ Time Frame: Post-baseline (at Week 4, 12, 20, 28, and 40 or endpoint) ] [ Designated as safety issue: Yes ]
Vital signs measured: sitting blood pressure, heart rate.
Markedly abnormal decreases: heart rate (HR) - if ≤50 bpm and decrease from baseline of ≥15 beats per minute (bpm); systolic blood pressure (SBP) - if ≤90 mm Hg and decrease from baseline of ≥20 mm Hg; diastolic blood pressure (DBP) - if ≤50 mm Hg and decrease from baseline of ≥15 mm Hg.
Markedly abnormal increases: HR - if ≥110 bpm and increase from baseline of ≥15 bpm; SBP - if ≥180 mm Hg and increase from baseline of ≥20 mm Hg; DBP - if ≥105 mm Hg and increase from baseline of ≥15 mm Hg.
- Number of Participants With Laboratory Values Outside Normal Range [ Time Frame: Week 40 or endpoint ] [ Designated as safety issue: Yes ]
Normal ranges were provided by the central laboratory.
Biochemistry = electrolytes, creatine kinase, liver enzymes, blood urea nitrogen, creatinine, alkaline phosphatase, protein, albumin
Metabolic chemistry = cholesterol, glucose, triglycerides, glycosylated hemoglobin
Endocrinology/miscellaneous = insulin, prolactin
Hematology = hemoglobin, red blood cell count, white blood cell count, platelets, hematocrit, neutrophils, lymphocytes, monocytes, eosinophils, basophils
|Study Start Date:||July 2005|
|Study Completion Date:||April 2007|
|Primary Completion Date:||April 2007 (Final data collection date for primary outcome measure)|
Asenapine 5-10 mg twice daily for 40 weeks
Asenapine, 40 weeks
Other Name: Org 5222
Active Comparator: Olanzapine
Olanzapine 5-20 mg once daily for 40 weeks
Olanzapine, 40 weeks
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