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NCT01987427 · ClinicalTrials.gov registry record · Phase 4
A Multicenter, Double-blind, Randomized, Parallel-group, Pilot Study of 12-week Duration to Assess the Short-term Safety and Tolerability of Lorcaserin Plus Two Doses of Immediate-Release Phentermine-HCl Compared With Lorcaserin Alone in Overweight and Obese Adults
A Phase 4 study, sponsored by Eisai.
- Completed
- Registry status
- Phase 4
- Development phase
- 344
- Enrollment target
NCT01987427 is a Phase 4 study that has completed, run by Eisai. The registered enrollment target is 344 participants.
The verdict
NCT01987427, a Phase 4 study, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 344 participants
- Enrollment target
Study Summary
APD356-A001-402 is a multicenter, double-blind, randomized, parallel-group pilot study of 12-week duration in overweight and obese adults. Approximately 225 subjects will be randomized to one of three treatment arms in a ratio 1:1:1 and will receive the combinations of lorcaserin 10 mg twice daily (BID) plus immediate-release phentermine-HCl 15 mg BID or 15 mg once daily (QD), or lorcaserin alone.
Interventions
- DRUG lorcaserin + phentermine placebo
- DRUG lorcaserin + phentermine-HCl + phentermine placebo
- DRUG lorcaserin + phentermine-HCl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 344 participants |
| Start Date | 2013-10-30 |
| Est. Completion | 2014-09-03 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01987427
The ClinicalTrials.gov registry entry for NCT01987427 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 344 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eisai, which has 287 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which lorcaserin + phentermine placebo is the first listed.
NCT01987427 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01987427 about?
NCT01987427 is a clinical study titled "A Multicenter, Double-blind, Randomized, Parallel-group, Pilot Study of 12-week Duration to Assess the Short-term Safety and Tolerability of Lorcaserin Plus Two Doses of Immediate-Release Phentermine-HCl Compared With Lorcaserin Alone in Overweight and Obese Adults". APD356-A001-402 is a multicenter, double-blind, randomized, parallel-group pilot study of 12-week duration in overweight and obese adults. Approximately 225 subjects will be randomized to one of three treatment arms in a ratio 1:1:1 and will receive the combinations of lorcaserin 10 mg twice daily (...
What is the current status of trial NCT01987427?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 344 participants. The study started on 2013-10-30. Estimated completion is 2014-09-03.
What interventions are being tested in trial NCT01987427?
The interventions under investigation include: lorcaserin + phentermine placebo (DRUG), lorcaserin + phentermine-HCl + phentermine placebo (DRUG), lorcaserin + phentermine-HCl (DRUG).
Who is sponsoring clinical trial NCT01987427?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
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