Safety and Efficacy of APD356 in the Treatment of Obesity
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|ClinicalTrials.gov Identifier: NCT00116740|
Recruitment Status : Completed
First Posted : July 1, 2005
Last Update Posted : March 25, 2010
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 a preliminary assessment of the safety and efficacy of APD356, when administered daily for 12 weeks, in obese subjects who are otherwise healthy. Subjects who are on concomitant medications for control of hypertension or blood lipids may qualify.
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Drug: APD356||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A 12-Week, Dose-Ranging, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of APD356 in Obese Patients|
|Study Start Date :||June 2005|
|Estimated Study Completion Date :||November 2005|
- Change in body weight
- Changes in waist circumference, hip circumference, and waist/hip ratio
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00116740
|United States, Louisiana|
|Pennington Biomedical Research Center|
|Baton Rouge, Louisiana, United States, 70808|
|Study Chair:||William R Shanahan, Jr., MD||Arena Pharmaceuticals|