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

NCT00677391 | Completed Phase 3

• 1 other identifier: MLAY-02-001
• Study Type: interventional
• Target: 103
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Change in bodyweight from baseline to final evaluation

  Wk 0, then, bi-weekly through duration of study

Secondary Outcomes (4)

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

  Wk 0 and Wk 24

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

  Wks 0, 12 and 24

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

  Wk 0 and Wk 24

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

  Wk 0, 12 and Wk 24. In addition to the stated time frames, a Quality of life survey was conducted 30 days post study.

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: Sibutramine

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Sibutramine DRUG

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

Also known as: ABT-991, Meridia, Reductil

1

Placebo DRUG

Capsules, once daily

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott: lead

MeSH Terms

Conditions

Obesity

Interventions

sibutramine

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 12, 2008
• First Posted: May 14, 2008
• Study Start: December 1, 2002
• Primary Completion: November 1, 2004
• Last Updated: May 14, 2008

Record last verified: 2008-05