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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00234988
Recruitment Status : Completed
First Posted : October 10, 2005
Last Update Posted : July 15, 2008
Information provided by:

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

Condition or disease Intervention/treatment Phase
Obesity Drug: sibutramine hydochloride monohydrate Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Weight Reduction of Sibutramine in the Treatment of Thai Obese and Overweight Subjects
Study Start Date : June 2004
Primary Completion Date : January 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Weight Control
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Weight loss [ Time Frame: 48 weeks ]
  2. Safety parameters [ Time Frame: 48 weeks ]

Secondary Outcome Measures :
  1. Waist and hip circumference [ Time Frame: 48 weeks ]
  2. Fasting glucose [ Time Frame: 48 weeks ]
  3. Fasting lipids [ Time Frame: 48 weeks ]
  4. Uric acid [ Time Frame: 48 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00234988

United States, Illinois
Global Medical Information - Abbott
North Chicago, Illinois, United States, 60064
Sponsors and Collaborators
Study Director: Global Medical Information 1-800-633-9110 Abbott

Responsible Party: Peter Bacher, MD, PhD, Abbott Identifier: NCT00234988     History of Changes
Other Study ID Numbers: THAI-03-002
First Posted: October 10, 2005    Key Record Dates
Last Update Posted: July 15, 2008
Last Verified: July 2008

Keywords provided by Abbott:

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms
Antidepressive Agents
Psychotropic Drugs
Appetite Depressants
Anti-Obesity Agents