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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

NCT01987427 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 344

Last updated 2019-09-30

Study results available
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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.

Conditions

Interventions

DRUG

lorcaserin + phentermine placebo

lorcaserin 10 mg BID + phentermine placebo BID

DRUG

lorcaserin + phentermine-HCl + phentermine placebo

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

DRUG

lorcaserin + phentermine-HCl

lorcaserin 10 mg BID + phentermine-HCl 15 mg BID

Sponsors & Collaborators

  • Eisai Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-30
Primary Completion
2014-08-31
Completion
2014-09-03

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01987427 on ClinicalTrials.gov