Efficacy and Safety Study of Sibutramine in Overweight Non-Diabetic Malaysian Population

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 subjects.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott
• Treatments: Sibutramine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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