CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 119 enrolled
Drug / intervention
Aripiprazoledrug
Likely dose
Aripiprazole 10-30 mg orally once dailyAI-extracted
Key inclusion· 2
  • ✓Currently receiving aripiprazole at screening
  • ✓Age 18 to 70 years
Key exclusion· 4
  • ✕Previously discontinued from any aripiprazole clinical trial for any reason
  • ✕Active alcohol or substance abuse
  • ✕Significant suicide risk
  • ✕Clinically significant abnormal laboratory results, vital signs, or ECG findings

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00239356
NCT00239356Phase 3Completed
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Aripiprazole (BMS-337039) for Outpatients With Schizophrenia Completing Aripiprazole Clinical Trials: A Non-Comparative Rollover Protocol

Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Oct 17, 2005·Updated Dec 19, 2014

In Brief

A Phase 3 clinical trial evaluating Aripiprazole for Schizophrenia. Completed, enrolled 119 participants across 20 sites in 11 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesCanada, Croatia, Czechia, France, Hungary, Netherlands, Poland, Romania, Russia, South Africa, United Kingdom
CollaboratorsOtsuka America Pharmaceutical

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 17, 2005
Enrollment StartMar 1, 2003
Primary CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 9.6 yearsPosted 20.7 years ago

Interventions

Aripiprazoledrug

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