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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.
Sponsored by: Abbott
Information provided by: Abbott
ClinicalTrials.gov Identifier: NCT00234988
  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 IV

MedlinePlus related topics: Obesity Weight Control
Drug Information available for: Sibutramine Sibutramine hydrochloride monohydrate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Safety and Weight Reduction of Sibutramine in the Treatment of Thai Obese and Overweight Subjects

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
1: Experimental Drug: sibutramine hydochloride monohydrate
10 mg QD with the option to increase dose to 15 mg QD up until Week 4

  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
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

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

Keywords provided by Abbott:
Sibutramine
Obesity

Study placed in the following topic categories:
Sibutramine
Body Weight
Signs and Symptoms
Obesity
 Weight Loss
Nutrition Disorders
Overnutrition
Overweight

Additional relevant MeSH terms:
Anti-Obesity Agents
Therapeutic Uses
Psychotropic Drugs
Appetite Depressants
 Central Nervous System Agents
Antidepressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009



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