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

Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Obesity

Intervention: Sibutramine (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Abbott

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.

Clinical Details

Official title: Randomized Trial of Obese Non-Diabetic Malaysians Using Sibutramine: A Randomized Double-Blind Placebo-Controlled Study of Sibutramine in the Management of Obese Subjects in Malaysia

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change in bodyweight from baseline to final evaluation

Secondary outcome:

The percentage of change in body weight from baseline to final evaluation.

Total body fat mass, total body lean mass, percent of total body lean mass measurements (Bodystat® 1500)

Total Abdominal Fat Mass, Total Abdominal Lean Mass, Percent of Total Abdominal Fat Mass and Percent of Total Abdominal Lean Mass (DEXA Scan)

metabolic measurements (Cholesterol, Triglycerides & Insulin resistance) and SF 36 Quality of life measurement

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: December 2002
Last updated: May 13, 2008

Page last updated: August 23, 2015

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