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

NCT ID: NCT00677391

Last Updated: 2008-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-12-31

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 subjects.

Conditions

Obesity

Keywords

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

Group Type: ACTIVE_COMPARATOR

Sibutramine

Intervention Type: DRUG

Capsules, Wk 0: 10mg, once daily; Wks 4-24: 10mg or 15mg, once daily, dosage escalation based upon investigator's assessment.

2

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Capsules, once daily

Interventions

Sibutramine

Capsules, Wk 0: 10mg, once daily; Wks 4-24: 10mg or 15mg, once daily, dosage escalation based upon investigator's assessment.

Intervention Type: DRUG

Placebo

Capsules, once daily

Intervention Type: DRUG

Other Intervention Names

ABT-991; Meridia; Reductil

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: lead

Responsible Party

Abbott

Other Identifiers

MLAY-02-001

Identifier Type: -

Identifier Source: org_study_id