CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 617 enrolled
Drug / intervention
Cariprazine +2 moredrug
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/NCT01104766
NCT01104766Phase 3Completed
CompareCT.gov

A Double-Blind, Placebo and Active-Controlled Evaluation of the Safety and Efficacy of Cariprazine in the Acute Exacerbation of Schizophrenia

Forest Laboratories·interventional·Posted Apr 15, 2010·Updated Oct 29, 2018

In Brief

A Phase 3 clinical trial evaluating Cariprazine, Aripiprazole, and 1 other intervention for Schizophrenia. Completed, enrolled 617 participants across 58 sites in 4 countries.

Detailed Summary

The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of acute exacerbation of schizophrenia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesRomania, Russia, Ukraine, United States
CollaboratorsGedeon Richter Ltd.

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 15, 2010
Enrollment StartApr 23, 2010
Primary CompletionDec 20, 2011
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 16.2 years ago

Interventions

Cariprazinedrug

Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.

Aripiprazoledrug

Patients who meet eligibility criteria will be administered a once daily oral dose of aripiprazole for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.

Placebodrug

Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.