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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ClinicalTrials.gov Identifier: NCT00234988 |
Recruitment Status :
Completed
First Posted : October 10, 2005
Last Update Posted : July 15, 2008
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Condition or disease | Intervention/treatment | Phase |
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Obesity | Drug: sibutramine hydochloride monohydrate | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 93 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Safety and Weight Reduction of Sibutramine in the Treatment of Thai Obese and Overweight Subjects |
Study Start Date : | June 2004 |
Actual Primary Completion Date : | January 2006 |

Arm | Intervention/treatment |
---|---|
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:
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- Weight loss [ Time Frame: 48 weeks ]
- Safety parameters [ Time Frame: 48 weeks ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00234988
United States, Illinois | |
Global Medical Information - Abbott | |
North Chicago, Illinois, United States, 60064 |
Study Director: | Global Medical Information 1-800-633-9110 | Abbott |
Responsible Party: | Peter Bacher, MD, PhD, Abbott |
ClinicalTrials.gov Identifier: | NCT00234988 |
Other Study ID Numbers: |
THAI-03-002 |
First Posted: | October 10, 2005 Key Record Dates |
Last Update Posted: | July 15, 2008 |
Last Verified: | July 2008 |
Sibutramine Obesity |
Overweight Body Weight Sibutramine Antidepressive Agents |
Psychotropic Drugs Appetite Depressants Anti-Obesity Agents |