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

History of Changes

Tracking Information

First Received Date ^ICMJE

March 1, 2005

Last Updated Date

February 1, 2010

Start Date ^ICMJE

December 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Change in body weight

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00104507 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Safety
Changes in waist circumference, hip circumference and waist/hip ratio

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Safety and Efficacy of APD356 in the Treatment of Obesity

Official Title ^ICMJE

A 4-Week, Dose-ranging, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety and Efficacy of APD356 in Obese Patients

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 obtain preliminary assessment of the safety and efficacy of APD356, when administered daily for 28 days, in obese subjects who are otherwise healthy.

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 nonpregnant, nonlactating, female volunteers, aged 18 to 65 years. Approximately 400 subjects will be enrolled.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Obesity

Intervention ^ICMJE

Drug: APD356

Study Arm (s)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

400

Completion Date

May 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00104507

Other Study ID Numbers ^ICMJE

APD356-003

Has Data Monitoring Committee

Responsible Party

Study Sponsor ^ICMJE

Arena Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

William R Shanahan, Jr, MD

Arena Pharmaceuticals

Information Provided By

Arena Pharmaceuticals

Verification Date

December 2006

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

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