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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.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00234988
First Posted: October 10, 2005
Last Update Posted: July 15, 2008
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.
Information provided by:
Abbott
  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
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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Weight loss [ Time Frame: 48 weeks ]
  • Safety parameters [ Time Frame: 48 weeks ]

Secondary Outcome Measures:
  • Waist and hip circumference [ Time Frame: 48 weeks ]
  • Fasting glucose [ Time Frame: 48 weeks ]
  • Fasting lipids [ Time Frame: 48 weeks ]
  • Uric acid [ Time Frame: 48 weeks ]

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

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
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
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
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

Responsible Party: Peter Bacher, MD, PhD, Abbott
ClinicalTrials.gov Identifier: NCT00234988     History of Changes
Other Study ID Numbers: THAI-03-002
First Submitted: September 13, 2005
First Posted: October 10, 2005
Last Update Posted: July 15, 2008
Last Verified: July 2008

Keywords provided by Abbott:
Sibutramine
Obesity

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