drugset / Trial / NCT01617200
Long-Term Safety Extension Trial of Asenapine in Schizophrenia Participants Who Completed Protocol P05688 (P05689)
Non-randomizedParallel-groupDouble-blindTreatment
Summary
Participants who have completed the 6-week trial P05688 can be screened for eligibility for this 26-week extension study in which they will continue treatment. The purpose of this trial is to evaluate the long-term safety of 2.5 and 5 mg asenapine administered sublingually twice daily (BID) in schizophrenia participants. Olanzapine administered 15 mg orally once daily (QD) is used as an active control.
Timeline
- Start
- 2012-12
- Primary completion
- 2015-03
- Completion
- 2015-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Asenapine | Other / unclassified | 2.5 mg | Subcutaneous |
| Subject | Asenapine | Other / unclassified | 5 mg | Subcutaneous |
| Subject | Olanzapine | Small molecule | 15 mg | Oral |