CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 344 enrolled
Drug / intervention
lorcaserin + phentermine placebo +2 moredrug
Likely dose
lorcaserin + phentermine placebo 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01987427
NCT01987427Phase 4Completed
CompareCT.gov

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

Eisai Inc.·interventional·Posted Nov 19, 2013·Updated Sep 30, 2019

In Brief

A Phase 4 clinical trial evaluating lorcaserin + phentermine placebo, lorcaserin + phentermine-HCl + phentermine placebo, and 1 other intervention for Chronic Weight Management. Completed, enrolled 344 participants across 13 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Weight Management
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 19, 2013
Enrollment StartOct 30, 2013
Primary CompletionAug 1, 2014
Study CompletionSep 3, 2014
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 12.6 years ago

Interventions

lorcaserin + phentermine placebodrug

lorcaserin 10 mg BID + phentermine placebo BID

lorcaserin + phentermine-HCl + phentermine placebodrug

lorcaserin 10 mg BID + phentermine-HCl 15 mg QD + phentermine placebo QD

lorcaserin + phentermine-HCldrug

lorcaserin 10 mg BID + phentermine-HCl 15 mg BID