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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.
This study has been completed.
Sponsor:
Abbott
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00234988
First received: September 13, 2005
Last updated: July 11, 2008
Last verified: July 2008
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Purpose
The purpose of the study is to determine the safety and weight loss when sibutramine is used in overweight and obese subjects.
| Condition | Intervention | Phase |
|---|---|---|
| Obesity | Drug: sibutramine hydochloride monohydrate | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Safety and Weight Reduction of Sibutramine in the Treatment of Thai Obese and Overweight Subjects |
Resource links provided by NLM:
Further study details as provided by Abbott:
Primary Outcome Measures:
- Weight loss [ Time Frame: 48 weeks ]
- Safety parameters [ Time Frame: 48 weeks ]
Secondary Outcome Measures:
- Waist and hip circumference [ Time Frame: 48 weeks ]
- Fasting glucose [ Time Frame: 48 weeks ]
- Fasting lipids [ Time Frame: 48 weeks ]
- Uric acid [ Time Frame: 48 weeks ]
| Enrollment: | 93 |
| Study Start Date: | June 2004 |
| Primary Completion Date: | January 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: sibutramine hydochloride monohydrate
10 mg QD with the option to increase dose to 15 mg QD up until Week 4
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00234988
Please refer to this study by its ClinicalTrials.gov identifier: NCT00234988
Locations
| United States, Illinois | |
| Global Medical Information - Abbott | |
| North Chicago, Illinois, United States, 60064 | |
Sponsors and Collaborators
Abbott
Investigators
| Study Director: | Global Medical Information 1-800-633-9110 | Abbott |
More Information
| Responsible Party: | Peter Bacher, MD, PhD, Abbott |
| ClinicalTrials.gov Identifier: | NCT00234988 History of Changes |
| Other Study ID Numbers: |
THAI-03-002 |
| Study First Received: | September 13, 2005 |
| Last Updated: | July 11, 2008 |
Keywords provided by Abbott:
|
Sibutramine Obesity |
Additional relevant MeSH terms:
|
Overweight Body Weight Signs and Symptoms Sibutramine |
Antidepressive Agents Psychotropic Drugs Appetite Depressants Anti-Obesity Agents |
ClinicalTrials.gov processed this record on June 22, 2017