Aripiprazole for Schizophrenia Outpatients Completing BMS Clinical Trials

Schizophrenia Clinical Trial

Official title:

Aripiprazole (BMS-337039) for Outpatients With Schizophrenia Completing Aripiprazole Clinical Trials: A Non-Comparative Rollover Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00239356
• Other study ID #: CN138-112
• Status: Completed
• Phase: Phase 3
• First received: October 13, 2005
• Last updated: December 4, 2014
• Start date: March 2003
• Est. completion date: October 2012

Study information

• Verified date: December 2014
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to provide aripiprazole to schizophrenic outpatients and Community Treated Patients who are currently receiving aripiprazole therapy on another BMS sponsored clinical trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Currently receiving aripiprazole at time of screening

• Men and women ages 18 to 70

Exclusion Criteria:

• All patients previously discontinued from an aripiprazole study for any reason

• Active alcohol or substance abuse

• Patients who represent a significant risk of committing suicide

• Patients with clinically significant abnormal laboratory test results, vital signs or ECG findings

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Aripiprazole
Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country

Locations

Country	Name	City	State
Canada	Local Institution	Ottawa	Ontario
Canada	Local Institution	Sherbrooke	Quebec
Croatia	Local Institution	Rijeka
Croatia	Local Institution	Zagreb
Czech Republic	Local Institution	Hradec Kralove
Czech Republic	Local Institution	Prague 6
France	Local Institution	Nantes Orvault
France	Local Institution	Rennes Cedex
France	Local Institution	Uzes
Hungary	Local Institution	Budapest
Hungary	Local Institution	Gyor
Netherlands	Local Institution	Vught
Poland	Local Institution	Krakow
Poland	Local Institution	Poznan
Romania	Local Institution	Bucharest
Russian Federation	Local Institution	St. Petersburg
South Africa	Local Institution	Cape Town	Western Cape
South Africa	Local Institution	Johannesburg	Gauteng
South Africa	Local Institution	Westdene	Free State
United Kingdom	Local Institution	Antrim

Sponsors (2)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.	Otsuka America Pharmaceutical

Countries where clinical trial is conducted

Canada,  Croatia,  Czech Republic,  France,  Hungary,  Netherlands,  Poland,  Romania,  Russian Federation,  South Africa,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Clinical Global Impression Severity Score (CGI-S) From Baseline Through End of Study- - Safety Population.	Baseline is Day 1 of the study, prior to first dose. CGI-S is a questionnaire completed by the clinician which evaluates the severity of mental illness of a participant at a specific point in time. It consists of 7 categories with the lower categories indicating less illness and the higher numbered categories indicating greater severity of illness: 0=not assessed; 1=normal, not at all ill; 2=borderline mentally ill; 3= mildly ill; 4=moderately ill; 5= markedly ill; 6=severely ill; 7=among the most extremely ill.	Baseline to Week 348	No
Secondary	Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuation Due to an AE - Safety Population	AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.	Baseline to Week 348	Yes
Secondary	Mean Exposure to Aripiprazole at Days 541 to 630, Days 721 to 810 and Days 1081 to 1170 - Safety Population	Mean exposure is mean number of milligrams per day (mg/day) of aripiprazole administered to the participants.	Day 1 to Day 1170	Yes
Secondary	Number of Participants With Potentially Clinically Relevant Chemistry Laboratory Abnormalities During Treatment - Safety Population	Clinically relevant abnormalities: greater than, equal to (>=); less than, equal to (<=). Upper limits of normal (ULN). milligram per deciliter (mg/dL); milliequivalent per liter (mEq/L); nanograms per milliliter (ng/mL);outside of normal range inclusive (): alanine transaminase (ALT>= 3*ULN; aspartate aminotransferase (AST >=3*ULN; alkaline phosphatase >=3*ULN; total bilirubin >= 2.0 mg/dL; blood urea nitrogen >= 30mg/dL; calcium (8.40 - 9.90 mg/dL); chloride (85.00 - 108.00 mEq/L); total cholesterol (140.0 - 200.0 mg/dL); cholesterol high density (HDL) and low density (LDL) lipoprotein (39.0 - 116.0 mg/dL); creatine kinase (15.0 - 170.0 U/L); creatinine >=2.0 mg/dL; prolactin (3.00 - 29.00 ng/mL); sodium (136.0 - 144.0 mEq/L); Glucose fasting (70.0 - 110.0 mg/dL); triglycerides (58.0 - 164.0 mg/dL; uric acid male >= 10.5, female >= 8.5mg/dL. Baseline is Day 1 of the study, prior to study drug administration.	Baseline to end of study (Week 348)	Yes
Secondary	Number of Participants With Potentially Clinically Relevant Hematology Laboratory Abnormalities During Treatment - Safety Population	Clinically relevant laboratory abnormality: Hemoglobin male <= 11.5 g/dL; female <= 9.5 g/dL. Hematocrit male <= 37 and 3 point decrease from baseline (BL); female <=32 and 3 point decrease from BL. Leukocytes <= 2800 mm^3 or >= 16000 mm^3; eosinophils >=10%. Baseline is Day 1 of the study, prior to study drug administration.	Baseline to end of study (Week 348)	Yes
Secondary	Number of Participants With Potentially Clinically Relevant Vital Sign Abnormality During Treatment - Safety Population	Vital signs include standing, sitting and supine systolic and diastolic blood pressure, measured in millimeters of mercury (mmHg) and standing, sitting and supine heart rate, measured in beats per minute. Baseline (BL) is Day 1 of the study, prior to study drug administration. Criteria for identifying vital sign values as clinically relevant: Systolic blood pressure (criterion value=90-180 mmHg) change relative to baseline: increase of greater than, equal to (>=) 20; decrease of >= 20 mmHg. Diastolic blood pressure (criterion value=50 - 105 mmHg) change relative to baseline: increase of >= 15; decrease of >= 15 mmHg. Heart rate (criterion value=50-120bpm) change relative to baseline: increase >=15; decreased >= 15 mmHg. To be clinically significantly abnormal: value must meet the criterion value and also represent a change from the participant's pre-treatment value of at least the magnitude shown in the change relative to baseline.	Baseline to end of study (Week 348)	Yes
Secondary	Number of Participants With Potentially Clinically Relevant ECG Abnormalities During Treatment - Safety Population	Potentially clinically relevant abnormality or change relative to baseline: sinus tachycardia: >= 120 beats per minute (bpm) and increased >= 15 bpm; sinus bradycardia: <= 50 bpm and decrease >= 15 bpm; supraventricular tachycardia, ventricular tachycardia, atrial fibrillation, atrial flutter: not present to present. First degree atrioventricular (A-V) block: PR interval(beginner of P wave to beginning of complex of Q, R, and S waves) >= 0.20 seconds (sec) and increase >= 0.05 sec; second and third degree A-V block, right bundle branch block (RBB) block, left bundle branch block (LBB) block: not present to present; other intraventricular block: QRS (complex of Q, R and S waves) >= 0.12 sec and increase >= 0.02 sec. Myocardial ischemia not present to present. QT interval with Bazett's correction (QTcB) or Fridericia's correction (QTcF) >= 450 milliseconds (msec) and elevation of 10% over baseline.	Baseline to end of study (Week 348	Yes

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm