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

NCT01395992 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2015-05-27

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Forest Laboratories

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2014-12-31
Completion
2015-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01395992 on ClinicalTrials.gov