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| Sponsor: | Abbott |
|---|---|
| Information provided by: | Abbott |
| ClinicalTrials.gov Identifier: | NCT00677391 |
Purpose
The primary objective of this study was to evaluate the efficacy and the safety of sibutramine vs. placebo in combination with a hypocaloric diet on weight-loss in overweight and obese Malaysian subjects.
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity |
Drug: Sibutramine Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment |
| Official Title: | Randomized Trial of Obese Non-Diabetic Malaysians Using Sibutramine: A Randomized Double-Blind Placebo-Controlled Study of Sibutramine in the Management of Obese Subjects in Malaysia |
| Enrollment: | 103 |
| Study Start Date: | December 2002 |
| Primary Completion Date: | November 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Active Comparator |
Drug: Sibutramine
Capsules, Wk 0: 10mg, once daily; Wks 4-24: 10mg or 15mg, once daily, dosage escalation based upon investigator's assessment.
|
| 2: Placebo Comparator |
Drug: Placebo
Capsules, once daily
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Dyslipidemia was defined as having at least one of the following three conditions:
If the subject was female
Exclusion Criteria:
Use within 4 weeks prior to Week 0 of any of the following:
Contacts and Locations
More Information
| Responsible Party: | Abbott ( Peter Bacher, Global Project Head ) |
| Study ID Numbers: | MLAY-02-001 |
| Study First Received: | May 12, 2008 |
| Last Updated: | May 13, 2008 |
| ClinicalTrials.gov Identifier: | NCT00677391 History of Changes |
| Health Authority: | Malaysia: Ministry of Health |
|
Obesity |
|
Obesity Psychotropic Drugs Overweight Pharmacologic Actions Body Weight Sibutramine Signs and Symptoms |
Anti-Obesity Agents Therapeutic Uses Nutrition Disorders Appetite Depressants Overnutrition Central Nervous System Agents Antidepressive Agents |