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

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

Date First Received: September 13, 2005

Last Updated: July 11, 2008

Verified by: Abbott, July 2008

Clinical Trial Phase: Phase 4 | Start Date: June 2004

Overall Status: Completed

Estimated Enrollment: 93

Brief Summary

Official Title: “Safety and Weight Reduction of Sibutramine in the Treatment of Thai Obese and Overweight Subjects”

Condition Keyword(s):

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

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2006

Intervention(s) in this Clinical Trial

  • Drug: sibutramine hydochloride monohydrate
    • 10 mg QD with the option to increase dose to 15 mg QD up until Week 4

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1

Outcome Measures for this Clinical Trial

Primary Measures

  • Weight loss
    • Time Frame: 48 weeks
      Safety Issue?: No
  • Safety parameters
    • Time Frame: 48 weeks
      Safety Issue?: Yes

Secondary Measures

  • Waist and hip circumference
    • Time Frame: 48 weeks
      Safety Issue?: No
  • Fasting glucose
    • Time Frame: 48 weeks
      Safety Issue?: Yes
  • Fasting lipids
    • Time Frame: 48 weeks
      Safety Issue?: Yes
  • Uric acid
    • Time Frame: 48 weeks
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Sponsor Information

Lead Sponsor: Abbott

Overall Clinical Trial Officials and Contacts

Global Medical Information 1-800-633-9110 Study Director Abbott  

Additional Information

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00234988

Study ID Number: THAI-03-002

ClinicalTrials.gov Identifier: NCT00234988

Health Authority: Thailand: Food and Drug Administration

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