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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: Completed Phase 4 study, sponsored by Eisai.
NCT01987427 is a Phase 4 study that has completed, run by Eisai. The registered enrollment target is 344 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (34% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The nine common serotonergic AEs were headache, dizziness, nausea, fatigue, dry mouth, diarrhea, vomiting, insomnia, and/or anxiety.
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 |
What the finished NCT01987427 record still lists
NCT01987427 is an interventional study that assigns participants to a tested intervention. The registered 344 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (34% lower).
The record links to 0 conditions, and to 3 interventions - of which lorcaserin + phentermine placebo is the first listed.
NCT01987427 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01987427's enrollment target sits among peer trials
344 245th of 2000 higher than 1,755 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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