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

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

July 11, 2008

Start Date ^ICMJE

June 2004

Primary Completion Date

January 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Weight loss [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Safety parameters [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Weight loss and safety

Change History

Complete list of historical versions of study NCT00234988 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Waist and hip circumference, fasting glucose, fasting lipids and uric acid.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Safety and Weight Reduction of Sibutramine in the Treatment of Thai Obese and Overweight Subjects

Brief Summary

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

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Obesity

Intervention ^ICMJE

Drug: sibutramine hydochloride monohydrate

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

January 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Subject has nutritional obesity and BMI >30 kg/m

Exclusion Criteria:

Type 1 or type 2 diabetes mellitus
Inadequately controlled hypertension
History of Gilles de la Tourette's Syndrome.
Use of any MAOIs, SSRIs, amino acids, antimigraine drugs, opioids
Hypothyroidism or hyperthyroidism.
History of:
- benign prostatic hyperplasia
- neurological disorders
- psychiatric illness
- severe renal or hepatic impairments
- narrow-angle glaucoma
History of cardiovascular disease or cerebrovascular disease
Persistent tachycardia at rest
Pulmonary hypertension
Phaeochromocytoma

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00234988

Responsible Party

Peter Bacher, MD, PhD, Abbott

Study ID Numbers ^ICMJE

THAI-03-002

Study Sponsor ^ICMJE

Abbott

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Global Medical Information 1-800-633-9110

Abbott

Information Provided By

Abbott

Verification Date

July 2008

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