MedDataX Logo

Aripiprazole for Schizophrenia Outpatients Completing BMS Clinical Trials

NCT ID: NCT00239356

Last Updated: 2014-12-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2012-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Schizophrenia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AI

Group Type EXPERIMENTAL

Aripiprazole

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Aripiprazole

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Abilify BMS-337039

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Otsuka America Pharmaceutical

INDUSTRY

Sponsor Role collaborator

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Local Institution

Ottawa, Ontario, Canada

Site Status

Local Institution

Sherbrooke, Quebec, Canada

Site Status

Local Institution

Rijeka, , Croatia

Site Status

Local Institution

Zagreb, , Croatia

Site Status

Local Institution

Hradec Králové, , Czechia

Site Status

Local Institution

Prague, , Czechia

Site Status

Local Institution

Nantes Orvault, , France

Site Status

Local Institution

Rennes, , France

Site Status

Local Institution

Uzès, , France

Site Status

Local Institution

Budapest, , Hungary

Site Status

Local Institution

Győr, , Hungary

Site Status

Local Institution

Vught, , Netherlands

Site Status

Local Institution

Krakow, , Poland

Site Status

Local Institution

Poznan, , Poland

Site Status

Local Institution

Bucharest, , Romania

Site Status

Local Institution

Saint Petersburg, , Russia

Site Status

Local Institution

Westdene, Free State, South Africa

Site Status

Local Institution

Johannesburg, Gauteng, South Africa

Site Status

Local Institution

Cape Town, Western Cape, South Africa

Site Status

Local Institution

Antrim, Antrim, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada Croatia Czechia France Hungary Netherlands Poland Romania Russia South Africa United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CN138-112

Identifier Type: -

Identifier Source: org_study_id