A Phase IV, Multi-Center, Open-Label Trial of Sibutramine in Combination With a Hypocaloric Diet in Obese and Overweight Thai Subjects.
Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obesity
Intervention: sibutramine hydochloride monohydrate (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Abbott Official(s) and/or principal investigator(s): Global Medical Information 1-800-633-9110, Study Director, Affiliation: Abbott
Summary
The purpose of the study is to determine the safety and weight loss when sibutramine is used
in overweight and obese subjects.
Clinical Details
Official title: Safety and Weight Reduction of Sibutramine in the Treatment of Thai Obese and Overweight Subjects
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Weight lossSafety parameters
Secondary outcome: Waist and hip circumferenceFasting glucose Fasting lipids Uric acid
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Global Medical Information - Abbott, North Chicago, Illinois 60064, United States
Additional Information
Starting date: June 2004
Last updated: July 11, 2008
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