NCT00905307

Study to Evaluate the Efficacy, Safety, and Tolerability of Oral OPC-34712 and Aripiprazole for Treatment of Acute Schizophrenia

A Phase 2, 6-Week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Oral OPC-34712 Once Daily and Aripiprazole Once Daily for Treatment of Hospitalized Adult Patients With Acute Schizophrenia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 459 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This will be a multicenter, randomized, double-blind, placebo-controlled study designed to assess the tolerability, safety, and efficacy of OPC-34712 (0.25 to 6.0 mg) for the treatment of adult subjects hospitalized with an acute relapse of schizophrenia. Aripiprazole (10 to 20 mg) is included as a positive control to confirm the assay sensitivity of the study. A total of approximately 563 subjects will be screened at an estimated 75 sites worldwide in order to obtain approximately 450 randomized subjects.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	OPC-34712	oral, once daily
DRUG	Placebo	Placebo
DRUG	Aripiprazole	oral, once daily

Timeline

• Start date: 2009-07-01
• Primary completion: 2010-09-01
• Completion: 2010-11-01
• First posted: 2009-05-20
• Last updated: 2015-10-20
• Results posted: 2015-09-03

Locations

73 sites across 12 countries: United States, Bulgaria, Croatia, India, Philippines, Romania, Russia, Serbia, Slovakia, South Korea, Taiwan, Ukraine