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Sponsored by: |
Arena Pharmaceuticals |
Information provided by: | Arena Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00104507 |
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 obtain preliminary assessment of the safety and efficacy of APD356, when administered daily for 28 days, in obese subjects who are otherwise healthy.
Condition | Intervention | Phase |
Obesity |
Drug: APD356 |
Phase II |
MedlinePlus related topics: | Obesity |
ChemIDplus related topics: | Serotonin APD-356 |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A 4-Week, Dose-Ranging, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of APD356 in Obese Patients |
Estimated Enrollment: | 400 |
Study Start Date: | December 2004 |
Estimated Study Completion Date: | May 2005 |
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 nonpregnant, nonlactating, female volunteers, aged 18 to 65 years. Approximately 400 subjects will be enrolled.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
United States, Louisiana | |||||
Pennington Biomedical Research Center | |||||
Baton Rouge, Louisiana, United States, 70808 |
Arena Pharmaceuticals |
Study Chair: | William R Shanahan, Jr, MD | Arena Pharmaceuticals |
obesity information 
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N. American Association for the Study of Obesity web page 
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sponsor company web page 
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Pennington Biomedical Research Center home web page 
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Study ID Numbers: | APD356-003 |
First Received: | March 1, 2005 |
Last Updated: | December 21, 2006 |
ClinicalTrials.gov Identifier: | NCT00104507 |
Health Authority: | United States: Food and Drug Administration |
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