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.
Minimum age: 18 Years.
Maximum age: 65 Years.
- 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
- 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
- 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
- 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