Status:
COMPLETED
A Phase IV, Multi-Center, Open-Label Trial of Sibutramine in Combination With a Hypocaloric Diet in Obese and Overweight Thai Subjects.
Lead Sponsor:
Abbott
Conditions:
Obesity
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The purpose of the study is to determine the safety and weight loss when sibutramine is used in overweight and obese subjects.
Eligibility Criteria
Inclusion
- Subject has nutritional obesity and BMI \>30 kg/m
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT00234988
Start Date
June 1 2004
Last Update
July 15 2008
Active Locations (1)
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1
Global Medical Information - Abbott
North Chicago, Illinois, United States, 60064