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NCT01467713 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Ramelteon Sublingual as Adjunctive Therapy for Maintenance Treatment of Bipolar I Disorder
A Phase 3 study, sponsored by Takeda.
- Terminated
- Registry status
- Phase 3
- Development phase
- 642
- Enrollment target
NCT01467713 is a Phase 3 study that was terminated before completion, run by Takeda. The registered enrollment target is 642 participants.
The verdict
NCT01467713, a Phase 3 study, was terminated before completion, sponsored by Takeda.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 642 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the efficacy and safety of ramelteon, once nightly before bedtime (QHS), sublingual (SL), in the maintenance treatment of Bipolar I Disorder in adult patients.
Interventions
- DRUG Placebo
- DRUG Ramelteon SL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 642 participants |
| Start Date | 2011-12 |
| Est. Completion | 2015-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01467713
The ClinicalTrials.gov registry entry for NCT01467713 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 642 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01467713 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01467713 about?
NCT01467713 is a clinical study titled "Efficacy and Safety of Ramelteon Sublingual as Adjunctive Therapy for Maintenance Treatment of Bipolar I Disorder". The purpose of this study is to determine the efficacy and safety of ramelteon, once nightly before bedtime (QHS), sublingual (SL), in the maintenance treatment of Bipolar I Disorder in adult patients.
What is the current status of trial NCT01467713?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 642 participants. The study started on 2011-12. Estimated completion is 2015-03.
What interventions are being tested in trial NCT01467713?
The interventions under investigation include: Placebo (DRUG), Ramelteon SL (DRUG).
Who is sponsoring clinical trial NCT01467713?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
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