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.

Sponsor:

Information provided by:

Abbott

ClinicalTrials.gov Identifier:

NCT00234988

First received: September 13, 2005

Last updated: July 11, 2008

Last verified: July 2008

History of Changes

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 4


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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: Weight Control

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

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

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
Experimental: 1	Drug: sibutramine hydochloride monohydrate 10 mg QD with the option to increase dose to 15 mg QD up until Week 4 Other Names: ABT-991 sibutramine Meridia

Eligibility


Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Keywords provided by Abbott:


Sibutramine Obesity

Additional relevant MeSH terms:


Sibutramine Anti-Obesity Agents Antidepressive Agents Appetite Depressants	Central Nervous System Agents Pharmacologic Actions Psychotropic Drugs Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015

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