Status:
COMPLETED
Efficacy and Safety Study of Sibutramine in Overweight Non-Diabetic Malaysian Population
Lead Sponsor:
Abbott
Conditions:
Obesity
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
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 subje...
Eligibility Criteria
Inclusion
- The subject did not adequately respond (i.e., did not achieve or maintain \> 5%weight loss) to an appropriate non-pharmacologic weight-reducing regimen (i.e., diet and exercise) within 3 months prior to Screening.
- The subject was male or female and between 18 and 65 years of age.
- The subject has nutritional obesity and BMI \>= 27 kg/m2 associated with dyslipidemia or has BMI \>= 30 kg/m2.
- Dyslipidemia was defined as having at least one of the following three conditions:
- Low-density lipoprotein (LDL)-cholesterol level of \> 3.4 mmol/L (\> 130 mg/dL)
- total cholesterol level of \> 5.2 mmol/L (\> 200 mg/dL)
- triglyceride level of \> 1.7 mmol/L (\> 150 mg/dL). 254
- If the subject was female
- she must either not of childbearing potential: defined as postmenopausal for at least 2 years or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy),
- or was of childbearing potential and practicing one of the following methods of birth control: condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD)on contraceptives (oral or parenteral) for the 3-month period prior to Week 0, a vasectomized partner, total abstinence from sexual intercourse
- If the subject was female, the results of a urine pregnancy test performed at Screening and Week 0 were negative.
- If the subject was female, the subject was not breast-feeding.
- The subject was judged to be in general good health based upon the results of medical history, complete physical examination and clinical laboratory tests.
- The subject was not taking any over-the-counter or prescription drugs, or herbal products for weight loss during the 4 week period prior to Screening.
- The subject has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior to undertaking any study-specific procedures
Exclusion
- History or evidence according to the 1997 American Diabetic Association (ADA)26criteria of type 1 or type 2 diabetes mellitus, i.e., fasting plasma glucose level \>= 7.0 mmol/L.
- Inadequately controlled hypertension having systolic blood pressure \>= 145 mmHg or diastolic blood pressure \>= 90 mmHg (average of three measurements) or any hypertensive subjects taking \> 3 medications to control blood pressure.
- History of Gilles de la Tourette's Syndrome.
- Use within 4 weeks prior to Week 0 of any of the following:
- Monoamine oxidase inhibitors (MAOIs): used to treat depression and Parkinson's disease.
- Medications that regulate the neurotransmitter serotonin in the brain (SSRIs): used to treat psychiatric disorders and to stop smoking.
- Amino acids: used to treat sleep disorders.
- Certain antimigraine drugs (such as sumatriptan, dihydroergotamine).
- Opioids (such as pentazocine, pethidine, fentanyl, dextromethorphan).
- Organic causes of obesity (e.g., hypothyroidism).
- History of major eating disorders, such as anorexia nervosa or bulimia nervosa.
- History of benign prostatic hyperplasia with urinary retention.
- History of neurological disorders such as seizures.
- History of documented psychiatric illnesses such as anxiety, depression, bipolar disorder or schizophrenia or having psychotic symptoms.
- History or evidence of severe renal or hepatic impairments.
- History of narrow-angle glaucoma.
- History of coronary artery disease, congestive heart failure, peripheral arterial occlusive disease, arrhythmia or cerebrovascular disease (transient ischemic attacks or strokes).13. History or evidence of hyperthyroidism.
- Persistent tachycardia at rest, i.e., heart rate \>100 bpm (average of 3 measurements).
- History of primary or secondary pulmonary hypertension.
- Underlying or suspected phaeochromocytoma.
- Known hypersensitivity to sibutramine hydrochloride monohydrate or any other component of the product.
- Known history of drug or alcohol abuse.
- Has previous history with the use of sibutramine.
- Any other medical illnesses judged by the investigator that may compromise the efficacy or safety of sibutramine.
- Unlikely to cooperate in the study
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT00677391
Start Date
December 1 2002
Last Update
May 14 2008
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