Aripiprazole for Schizophrenia Outpatients Completing BMS Clinical Trials
This study is ongoing, but not recruiting participants.
Sponsor:
Bristol-Myers Squibb
Collaborator:
Otsuka America Pharmaceutical
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00239356
First received: October 13, 2005
Last updated: February 17, 2012
Last verified: February 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: Aripiprazole |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Aripiprazole (BMS-337039) for Outpatients With Schizophrenia Completing Aripiprazole Clinical Trials: A Non-Comparative Rollover Protocol |
Resource links provided by NLM:
MedlinePlus related topics:
Schizophrenia
Drug Information available for:
Aripiprazole
U.S. FDA Resources
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Clinical Global Impression [ Time Frame: Severity will be summarized over time ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety assessments [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 400 |
| Study Start Date: | March 2003 |
| Estimated Study Completion Date: | November 2012 |
| Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: AI |
Drug: Aripiprazole
Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00239356
Locations
| Canada, Ontario | |
| Local Institution | |
| Ottawa, Ontario, Canada | |
| Canada, Quebec | |
| Local Institution | |
| Sherbrooke, Quebec, Canada | |
| Croatia | |
| Local Institution | |
| Rijeka, Croatia | |
| Local Institution | |
| Zagreb, Croatia | |
| Czech Republic | |
| Local Institution | |
| Hradec Kralove, Czech Republic | |
| Local Institution | |
| Prague 6, Czech Republic | |
| France | |
| Local Institution | |
| Nantes Orvault, France | |
| Local Institution | |
| Rennes Cedex, France | |
| Local Institution | |
| Uzes, France | |
| Hungary | |
| Local Institution | |
| Budapest, Hungary | |
| Local Institution | |
| Gyor, Hungary | |
| Netherlands | |
| Local Institution | |
| Vught, Netherlands | |
| Poland | |
| Local Institution | |
| Krakow, Poland | |
| Local Institution | |
| Poznan, Poland | |
| Romania | |
| Local Institution | |
| Bucharest, Romania | |
| Russian Federation | |
| Local Institution | |
| St. Petersburg, Russian Federation | |
| South Africa | |
| Local Institution | |
| Westdene, Free State, South Africa | |
| Local Institution | |
| Johannesburg, Gauteng, South Africa | |
| Local Institution | |
| Cape Town, Western Cape, South Africa | |
| United Kingdom | |
| Local Institution | |
| Antrim, United Kingdom | |
Sponsors and Collaborators
Bristol-Myers Squibb
Otsuka America Pharmaceutical
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00239356 History of Changes |
| Other Study ID Numbers: | CN138-112 |
| Study First Received: | October 13, 2005 |
| Last Updated: | February 17, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Aripiprazole Antipsychotic Agents Tranquilizing Agents |
Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |
ClinicalTrials.gov processed this record on June 18, 2013