NCT01395992

Long-Term Safety Extension Trial of Asenapine in Bipolar 1 Disorder Participants Who Completed Protocol P05691 (P05692)

A Multicenter, Double-Blind, Fixed-Dose, Long-Term Extension Trial of the Safety of Asenapine in Subjects Diagnosed With Bipolar 1 Disorder Who Completed Protocol P05691 (Formerly 041044) (Phase3B, Protocol P05692 [Formerly 041045])

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 165 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Participants who have completed the 3-week trial P05691 (NCT00764478) can be screened for eligibility for this 26-week extension study in which they will continue treatment. The primary purpose of this trial is to evaluate the long-term safety of asenapine.

Conditions

• Bipolar I Disorder

Interventions

Type	Name	Description
DRUG	asenapine	asenapine 5 mg tablet, sublingually (SL) twice daily (BID) for 182 days
DRUG	asenapine	asenapine 10 mg tablet, SL BID for 182 days

Timeline

• Start date: 2012-04-01
• Primary completion: 2014-12-01
• Completion: 2015-01-01
• First posted: 2011-07-18
• Last updated: 2015-05-27

Locations

1 site across 1 country: United States