CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 403 enrolled
Drug / intervention
Cariprazinedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT01059539
NCT01059539Phase 3Completed
CompareCT.gov

A Long-term Open-label Study of the Safety and Tolerability of Cariprazine in Patients With Bipolar I Disorder

Forest Laboratories·interventional·Posted Feb 1, 2010·Updated Jun 13, 2019

In Brief

A Phase 3 clinical trial evaluating Cariprazine for Bipolar I Disorder. Completed, enrolled 403 participants across 35 sites in 4 countries.

Detailed Summary

The objective of this study is to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with bipolar I disorder.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar I Disorder
CountriesHungary, Poland, Spain, United States
CollaboratorsGedeon Richter Ltd.

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 1, 2010
Enrollment StartFeb 28, 2010
Primary CompletionFeb 29, 2012
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 16.4 years ago

Interventions

Cariprazinedrug

Cariprazine was supplied in capsules.