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NCT01617200 · ClinicalTrials.gov registry record · Phase 3
Long-Term Safety Extension Trial of Asenapine in Schizophrenia Participants Who Completed Protocol P05688 (P05689)
A Phase 3 study, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 105
- Enrollment target
NCT01617200: Completed Phase 3 study, sponsored by Forest Laboratories.
NCT01617200 is a Phase 3 study that has completed, run by Forest Laboratories. The registered enrollment target is 105 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01617200, a Phase 3 study, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 105 participants
- Enrollment target
Study 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.
Interventions
- DRUG Olanzapine
- DRUG Asenapine
- DRUG Placebo Asenapine
- DRUG Placebo Olanzapine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2012-12 |
| Est. Completion | 2015-03 |
| Phase | Phase 3 |
What the finished NCT01617200 record still lists
NCT01617200 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 4 interventions - of which Olanzapine is the first listed.
NCT01617200 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01617200 about?
NCT01617200 is a clinical study titled "Long-Term Safety Extension Trial of Asenapine in Schizophrenia Participants Who Completed Protocol P05688 (P05689)". 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 schiz...
What is the current status of trial NCT01617200?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 105 participants. The study started on 2012-12. Estimated completion is 2015-03.
What interventions are being tested in trial NCT01617200?
The interventions under investigation include: Olanzapine (DRUG), Asenapine (DRUG), Placebo Asenapine (DRUG), Placebo Olanzapine (DRUG).
Who is sponsoring clinical trial NCT01617200?
This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01617200's enrollment target sits among peer trials
105 1670th of 2000 higher than 330 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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