Safety and Efficacy of APD356 in the Treatment of Obesity

This study has been completed.
Sponsor:
Information provided by:
Arena Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00104507
First received: March 1, 2005
Last updated: February 1, 2010
Last verified: December 2006

March 1, 2005
February 1, 2010
December 2004
Not Provided
Change in body weight
Same as current
Complete list of historical versions of study NCT00104507 on ClinicalTrials.gov Archive Site
  • Safety
  • Changes in waist circumference, hip circumference and waist/hip ratio
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of APD356 in the Treatment of Obesity
A 4-Week, Dose-ranging, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety and Efficacy of APD356 in Obese Patients

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Obesity
Drug: APD356
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
May 2005
Not Provided
  • 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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00104507
APD356-003
Not Provided
Not Provided
Arena Pharmaceuticals
Not Provided
Study Chair: William R Shanahan, Jr, MD Arena Pharmaceuticals
Arena Pharmaceuticals
December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP