Status:
COMPLETED
Safety and Efficacy of APD356 in the Treatment of Obesity
Lead Sponsor:
Eisai Inc.
Conditions:
Obesity
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This is a research study of an investigational drug, APD356, a novel, selective 5-HT2c receptor agonist, in clinical development as a potential treatment for obesity. The purpose of this study is to ...
Detailed Description
This is a double-blind, placebo-controlled, randomized, parallel group study. Three different doses of APD356 or placebo will be administered daily for 28 days, to uncomplicated obese, male and nonpre...
Eligibility Criteria
Inclusion
- Healthy male or nonpregnant, nonlactating females aged between 18 and 65 years (inclusive)
- Body Mass Index (BMI) of 30-45 Kg/m\^2.
- Non-smoker
- No concomitant medications
- No past treatment with drugs associated with the development of pulmonary hypertension or cardiac valvular insufficiency
Exclusion
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
End Date :
May 1 2005
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00104507
Start Date
December 1 2004
End Date
May 1 2005
Last Update
September 12 2019
Active Locations (1)
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1
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808