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

Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Obesity

Intervention: sibutramine hydochloride monohydrate (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Global Medical Information 1-800-633-9110, Study Director, Affiliation: Abbott

Summary

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

Clinical Details

Official title: Safety and Weight Reduction of Sibutramine in the Treatment of Thai Obese and Overweight Subjects

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Weight loss

Safety parameters

Secondary outcome:

Waist and hip circumference

Fasting glucose

Fasting lipids

Uric acid

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Global Medical Information - Abbott, North Chicago, Illinois 60064, United States
Additional Information

Starting date: June 2004
Last updated: July 11, 2008

Page last updated: August 23, 2015

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