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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.
 
ClinicalTrials.gov Identifier: NCT00234988
Recruitment Status : Completed
First Posted : October 10, 2005
Last Update Posted : July 15, 2008
Sponsor:
Information provided by:
Abbott

Study Description
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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 Design
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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
Actual Primary Completion Date : January 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Weight Control

Arms and Interventions
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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


Outcome Measures
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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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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 ClinicalTrials.gov identifier (NCT number): NCT00234988


Locations
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United States, Illinois
Global Medical Information - Abbott
North Chicago, Illinois, United States, 60064
Sponsors and Collaborators
Abbott
Investigators
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Study Director: Global Medical Information 1-800-633-9110 Abbott
More Information
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Responsible Party: Peter Bacher, MD, PhD, Abbott
ClinicalTrials.gov Identifier: NCT00234988    
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:
Sibutramine
Obesity
Additional relevant MeSH terms:
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Overweight
Body Weight
Sibutramine
Antidepressive Agents
 Psychotropic Drugs
Appetite Depressants
Anti-Obesity Agents