None listed
Conditions
Interventions
Intervention1: R-Sibutramine: 4.18 mg or 6.28 mg once daily for six months
Control Intervention1: Sibutramine: 8.37 mg or 12.55 mg once daily for six months
Sponsors
Emcure Pharmaceuticals Ltd., Pune
Eligibility
Inclusion criteria
Inclusion criteria: Subjects with body mass index greater than 27 kg/m2 Subjects of either sex and aged between 18-65 years
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decrease in body weight and body mass index Decrease in waist circumference and waist:hip ratio Timepoint: 0,1,2,3,4,5,6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Decrease in appetite Increase in satiety Timepoint: 0,1,2,3,4,5,6 months | — |
Countries
India
Contacts
Public ContactDr. Sandeep Sonawane
Manager- Medical Services
Outcome results
None listed