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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	19 October 2017
Main ID:	NCT00239356
Date of registration:	13/10/2005
Prospective Registration:	No
Primary sponsor:	Otsuka Pharmaceutical Development & Commercialization, Inc.
Public title:	Aripiprazole for Schizophrenia Outpatients Completing BMS Clinical Trials
Scientific title:	Aripiprazole (BMS-337039) for Outpatients With Schizophrenia Completing Aripiprazole Clinical Trials: A Non-Comparative Rollover Protocol
Date of first enrolment:	March 2003
Target sample size:	119
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT00239356
Study type:	Interventional
Study design:
Phase:	Phase 3

Countries of recruitment
Canada	Croatia	Czech Republic	France	Hungary	Netherlands	Poland	Romania
Russian Federation	South Africa	United Kingdom

Contacts

Name:	Bristol-Myers Squibb
Address:
Telephone:
Email:
Affiliation:	Bristol-Myers Squibb

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Schizophrenia

Intervention(s)

Drug: Aripiprazole

Primary Outcome(s)

Mean Clinical Global Impression Severity Score (CGI-S) From Baseline Through End of Study- - Safety Population. [Time Frame: Baseline to Week 348]

Secondary Outcome(s)

Number of Participants With Potentially Clinically Relevant Vital Sign Abnormality During Treatment - Safety Population [Time Frame: Baseline to end of study (Week 348)]

Number of Participants With Potentially Clinically Relevant ECG Abnormalities During Treatment - Safety Population [Time Frame: Baseline to end of study (Week 348]

Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuation Due to an AE - Safety Population [Time Frame: Baseline to Week 348]

Number of Participants With Potentially Clinically Relevant Chemistry Laboratory Abnormalities During Treatment - Safety Population [Time Frame: Baseline to end of study (Week 348)]

Mean Exposure to Aripiprazole at Days 541 to 630, Days 721 to 810 and Days 1081 to 1170 - Safety Population [Time Frame: Day 1 to Day 1170]

Number of Participants With Potentially Clinically Relevant Hematology Laboratory Abnormalities During Treatment - Safety Population [Time Frame: Baseline to end of study (Week 348)]

Secondary ID(s)

CN138-112

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Otsuka America Pharmaceutical

Ethics review

Results

Results available:	Yes
Date Posted:	10/01/2014
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT00239356

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