A Phase IV, Multi-Center, Open-Label Trial of Sibutramine in Combination With a Hypocaloric Diet in Obese and Overweight Thai Subjects.

This study has been completed.

First Received: September 13, 2005 Last Updated: July 11, 2008 History of Changes

Sponsor:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00234988

Purpose

The purpose of the study is to determine the safety and weight loss when sibutramine is used in overweight and obese subjects.

Condition	Intervention	Phase
Obesity	Drug: sibutramine hydochloride monohydrate	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Safety and Weight Reduction of Sibutramine in the Treatment of Thai Obese and Overweight Subjects

Resource links provided by NLM:

MedlinePlus related topics: Diets Obesity Weight Control

Further study details as provided by Abbott:

Primary Outcome Measures:

Secondary Outcome Measures:

Waist and hip circumference [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Fasting glucose [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
Fasting lipids [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
Uric acid [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	93
Study Start Date:	June 2004
Primary Completion Date:	January 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: sibutramine hydochloride monohydrate 10 mg QD with the option to increase dose to 15 mg QD up until Week 4

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00234988

Locations

United States, Illinois
Global Medical Information - Abbott
North Chicago, Illinois, United States, 60064

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Global Medical Information 1-800-633-9110

Abbott

More Information

No publications provided

Responsible Party:	Abbott ( Peter Bacher, MD, PhD )
Study ID Numbers:	THAI-03-002
Study First Received:	September 13, 2005
Last Updated:	July 11, 2008
ClinicalTrials.gov Identifier:	NCT00234988 History of Changes
Health Authority:	Thailand: Food and Drug Administration

Keywords provided by Abbott:

Sibutramine
Obesity

Additional relevant MeSH terms:

Obesity
Psychotropic Drugs
Overweight
Pharmacologic Actions
Body Weight
Sibutramine
Signs and Symptoms

Anti-Obesity Agents
Therapeutic Uses
Nutrition Disorders
Appetite Depressants
Overnutrition
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on November 27, 2009