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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:
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:

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
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:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Sibutramine
 Appetite Depressants
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on June 18, 2013