A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Fixed-Dose Clinical Trial Evaluating The Efficacy, Safety And Tolerability Of Cariprazine In Patients With Bipolar I Depression
Phase of Trial: Phase III
Latest Information Update: 12 Apr 2018
At a glance
- Drugs Cariprazine (Primary)
- Indications Bipolar I disorders
- Focus Therapeutic Use
- Sponsors Allergan; Forest Laboratories
- 03 Apr 2018 According to the Allergan media release, company plans to include data from this and other two pivotal trials (700202873 and 700267785) in the Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2018.
- 03 Apr 2018 Primary endpoint change from Baseline Montgomery-sberg Depression Rating Scale (MADRS) for the cariprazine 3 mg dose group versus placebo, has not been met.
- 03 Apr 2018 Primary endpoint change from Baseline Montgomery-sberg Depression Rating Scale (MADRS) for the cariprazine 1.5 mg dose group versus placebo has been met.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History