CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 446 enrolled
Drug / intervention
Cariprazine +1 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/NCT01104779
NCT01104779Phase 3Completed
CompareCT.gov

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

Forest Laboratories·interventional·Posted Apr 15, 2010·Updated Nov 14, 2018

In Brief

A Phase 3 clinical trial evaluating Cariprazine and Placebo for Schizophrenia. Completed, enrolled 446 participants across 41 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
CountriesColombia, India, South Africa, United States
CollaboratorsGedeon Richter Ltd.

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 15, 2010
Enrollment StartApr 27, 2010
Primary CompletionDec 15, 2011
TodayJul 2, 2026
Enrollment to primary: 1.6 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.

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.