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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 is a Phase 3 study that has completed, run by Forest Laboratories. The registered enrollment target is 105 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01617200
The ClinicalTrials.gov registry entry for NCT01617200 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 105 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Forest Laboratories, which has 145 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Olanzapine is the first listed.
NCT01617200 reports 0 study locations.
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.
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