Trials / Completed
CompletedNCT00265343
6-Month Extension Trial of Asenapine With Olanzapine in Negative Symptom Patients Who Completed the Protocol 25543 (25544)(P05777)
A Multicenter, Double-Blind, Flexible-Dose, 6-Month Extension Trial Comparing the Safety and Efficacy of Asenapine With Olanzapine in Subjects Who Completed the Protocol 25543 (NCT 00212836; P05817)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 306 (actual)
- Sponsor
- Organon and Co · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is an extension study to further test the efficacy and safety of asenapine compared with a marketed agent (olanzapine) in the treatment of patients with persistent negative symptoms of schizophrenia.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | asenapine | 5-10 mg sublingually twice daily for 26 weeks |
| DRUG | olanzapine | 5-20 mg by mouth once daily for 26 weeks |
Timeline
- Start date
- 2005-12-01
- Primary completion
- 2007-12-01
- Completion
- 2008-01-01
- First posted
- 2005-12-14
- Last updated
- 2022-02-09
- Results posted
- 2010-02-23
Source: ClinicalTrials.gov record NCT00265343. Inclusion in this directory is not an endorsement.