CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 97 enrolled
Drug / intervention
Cariprazinedrug
Likely dose
Not stated in record
Key inclusion· 4
  • ✓Completion of double-blind treatment period in lead-in study RGH-MD-16
  • ✓Response to prior treatment defined as ≥20% reduction in PANSS total score from baseline and CGI-S score ≤3
  • ✓Eligible to continue as outpatient per investigator
  • ✓Must have a caregiver to ensure treatment compliance
Key exclusion· 1
  • ✕Clinically significant abnormalities on physical examination, laboratory tests, vital signs, or ECG

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

Search/NCT00839852
NCT00839852Phase 2Completed
CompareCT.gov

A Long-term, Open-label Extension Study of the Safety and Tolerability of RGH-188 (Cariprazine) in Patients With Schizophrenia

Forest Laboratories·interventional·Posted Feb 10, 2009·Updated Aug 22, 2019

In Brief

A Phase 2 clinical trial evaluating Cariprazine for Schizophrenia. Completed, enrolled 97 participants across 65 sites in 5 countries.

Detailed Summary

This is an outpatient study to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with schizophrenia.

Study Details

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

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 10, 2009
Enrollment StartMay 31, 2009
Primary CompletionAug 31, 2010
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.4 years ago

Interventions

Cariprazinedrug

Cariprazine was supplied in capsules.