Back to resultsA Phase IV, Multi-Center, Open-Label Trial of Sibutramine in Combination With a Hypocaloric Diet in Obese and Overweight Thai Subjects.
Primary Purpose
Obesity
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
sibutramine hydochloride monohydrate
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Sibutramine, Obesity
Eligibility 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
Sites / Locations
- Global Medical Information - Abbott
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Weight loss
Safety parameters
Secondary Outcome Measures
Waist and hip circumference
Fasting glucose
Fasting lipids
Uric acid
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00234988
Brief Title
A Phase IV, Multi-Center, Open-Label Trial of Sibutramine in Combination With a Hypocaloric Diet in Obese and Overweight Thai Subjects.
Official Title
Safety and Weight Reduction of Sibutramine in the Treatment of Thai Obese and Overweight Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Abbott
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to determine the safety and weight loss when sibutramine is used in overweight and obese subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Sibutramine, Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
93 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
sibutramine hydochloride monohydrate
Other Intervention Name(s)
ABT-991, sibutramine, Meridia
Intervention Description
10 mg QD with the option to increase dose to 15 mg QD up until Week 4
Primary Outcome Measure Information:
Title
Weight loss
Time Frame
48 weeks
Title
Safety parameters
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Waist and hip circumference
Time Frame
48 weeks
Title
Fasting glucose
Time Frame
48 weeks
Title
Fasting lipids
Time Frame
48 weeks
Title
Uric acid
Time Frame
48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Medical Information 1-800-633-9110
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Global Medical Information - Abbott
City
North Chicago
State/Province
Illinois
ZIP/Postal Code
60064
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Phase IV, Multi-Center, Open-Label Trial of Sibutramine in Combination With a Hypocaloric Diet in Obese and Overweight Thai Subjects.
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