efficacy and safety study of sibutramine in overweight non-diabetic malaysian population

Conditions: Obesity

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.


Eligibility 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

Keywords: obesity