A Phase IV, Multi-Center, Open-Label Trial of Sibutramine in Combination With a Hypocaloric Diet in Obese and Overweight Thai Subjects.

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to determine the safety and weight loss when sibutramine is used in overweight and obese subjects.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott
• Treatments: Sibutramine

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