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

Phase 4

Completed

• Conditions: Obesity
• Interventions: Drug: sibutramine hydochloride monohydrate

• Registration Number: NCT00234988
• Lead Sponsor: Abbott

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-10-07
• Study First Posted: 2005-10-10
• Primary Completion: 2006-01
• Status Verified: 2008-07
• Last Update Submitted: 2008-07-11
• Last Update Posted: 2008-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	sibutramine hydochloride monohydrate	-

Primary Outcome Measures

Name	Time	Method
Weight loss	48 weeks
Safety parameters	48 weeks

Secondary Outcome Measures

Name	Time	Method
Waist and hip circumference	48 weeks
Fasting glucose	48 weeks
Fasting lipids	48 weeks
Uric acid	48 weeks

Trial Locations

Locations (1)

Global Medical Information - Abbott; 🇺🇸 North Chicago, Illinois, United States