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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00677391
First received: May 12, 2008
Last updated: May 13, 2008
Last verified: May 2008
  Purpose

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.


Condition Intervention Phase
Obesity
Drug: Sibutramine
Drug: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Change in bodyweight from baseline to final evaluation [ Time Frame: Wk 0, then, bi-weekly through duration of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The percentage of change in body weight from baseline to final evaluation. [ Time Frame: Wk 0 and Wk 24 ] [ Designated as safety issue: No ]
  • Total body fat mass, total body lean mass, percent of total body lean mass measurements (Bodystat® 1500) [ Time Frame: Wks 0, 12 and 24 ] [ Designated as safety issue: No ]
  • Total Abdominal Fat Mass, Total Abdominal Lean Mass, Percent of Total Abdominal Fat Mass and Percent of Total Abdominal Lean Mass (DEXA Scan) [ Time Frame: Wk 0 and Wk 24 ] [ Designated as safety issue: No ]
  • metabolic measurements (Cholesterol, Triglycerides & Insulin resistance) and SF 36 Quality of life measurement [ Time Frame: Wk 0, 12 and Wk 24. In addition to the stated time frames, a Quality of life survey was conducted 30 days post study. ] [ Designated as safety issue: No ]

Enrollment: 103
Study Start Date: December 2002
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: Sibutramine
Capsules, Wk 0: 10mg, once daily; Wks 4-24: 10mg or 15mg, once daily, dosage escalation based upon investigator's assessment.
Other Names:
  • ABT-991
  • Sibutramine
  • Meridia
  • Reductil
Placebo Comparator: 2 Drug: Placebo
Capsules, once daily
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Peter Bacher, Global Project Head, Abbott
ClinicalTrials.gov Identifier: NCT00677391     History of Changes
Other Study ID Numbers: MLAY-02-001
Study First Received: May 12, 2008
Last Updated: May 13, 2008
Health Authority: Malaysia: Ministry of Health

Keywords provided by Abbott:
Obesity

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Sibutramine
Appetite Depressants
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on April 15, 2014