A Phase IV, Multi-Center, Open-Label Trial of Sibutramine in Combination With a Hypocaloric Diet in Obese and Overweight Thai Subjects.
July 11, 2008 updated by: Abbott
Safety and Weight Reduction of Sibutramine in the Treatment of Thai Obese and Overweight Subjects
The purpose of the study is to determine the safety and weight loss when sibutramine is used in overweight and obese subjects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
93
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Illinois
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North Chicago, Illinois, United States, 60064
- Global Medical Information - Abbott
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: 1
|
10 mg QD with the option to increase dose to 15 mg QD up until Week 4
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Weight loss
Time Frame: 48 weeks
|
48 weeks
|
|
Safety parameters
Time Frame: 48 weeks
|
48 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Waist and hip circumference
Time Frame: 48 weeks
|
48 weeks
|
|
Fasting glucose
Time Frame: 48 weeks
|
48 weeks
|
|
Fasting lipids
Time Frame: 48 weeks
|
48 weeks
|
|
Uric acid
Time Frame: 48 weeks
|
48 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2004
Primary Completion (ACTUAL)
January 1, 2006
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
October 7, 2005
First Posted (ESTIMATE)
October 10, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
July 15, 2008
Last Update Submitted That Met QC Criteria
July 11, 2008
Last Verified
July 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- THAI-03-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.