A clinical trial to compare two drugs, R-Sibutramine and Sibutramine, in the management of obesity
- Registration Number
- CTRI/2008/091/000265
- Lead Sponsor
- Emcure Pharmaceuticals Ltd., Pune
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
Subjects with body mass index greater than 27 kg/m2
Subjects of either sex and aged between 18-65 years
Known hypersensitivity to Sibutramine
Concomitant use of MAO inhibitors, centrally acting appetite suppressants, other centrally acting drugs, drugs that affect hemostasis or platelet function
Drug, tobacco or alcohol abuse
Psychiatric disorders
Endocrine disease other than type II diabetes
History of arrhythmias, congestive heart failure, coronary artery disease, stroke, seizures
Severe hypertension
Pulmonary hypertension
Benign prostatic hyperplasia with urinary retention
Phaeochromocytoma
Hyperthyroidism
Untreated hypothyroidism
Severe renal or hepatic impairment
Narrow angle glaucoma
Predisposal to bleeding events
Lactating or pregnant women or women of childbearing potential not practicing an effective mode of contraception
Organic causes of obesity e.g. Cushing?s syndrome, hypogonadism, congenital disorders, lipodystrophy, lipoatrophy etc.
History of major eating disorders
Any condition that, in the opinion of the investigator, does not justify the patient?s inclusion in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method