ObesityPhase 3NCT00677391
Efficacy and Safety Study of Sibutramine in Overweight Non-Diabetic Malaysian Population
A Phase 3 study testing Sibutramine in people with Obesity, run by Abbott.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Sibutramine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- No sites listed yet
- Study dates
- Dec 2002to Nov 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 15Show fewer
- 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
Who cannot join
- 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.
Show all 25Show fewer
- 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
About this study
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
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
- Being tested
- Sibutramine, Placebo
- Keywords
- Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SibutramineDrug
Also called ABT-991, Meridia, Reductil
Capsules, Wk 0: 10mg, once daily; Wks 4-24: 10mg or 15mg, once daily, dosage escalation based upon investigator's assessment.
PlaceboDrug
Capsules, once daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: Sibutramine |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bodyweight from baseline to final evaluation
Measured: Wk 0, then, bi-weekly through duration of study
Secondary outcomes (4)
The percentage of change in body weight from baseline to final evaluation.
Measured: Wk 0 and Wk 24
Total body fat mass, total body lean mass, percent of total body lean mass measurements (Bodystat® 1500)
Measured: 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)
Measured: Wk 0 and Wk 24
metabolic measurements (Cholesterol, Triglycerides & Insulin resistance) and SF 36 Quality of life measurement
Measured: Wk 0, 12 and Wk 24. In addition to the stated time frames, a Quality of life survey was conducted 30 days post study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2008 (estimated)
- Study startDec 2002
- Primary completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00677391
- Sponsor's protocol ID
- MLAY-02-001
- Status last verified
- May 2008
- First submitted
- 12 May 2008
- Last updated
- 14 May 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00677391
- Acronym / sponsor ID
- MLAY-02-001
- Conditions
- Obesity
- Keywords
- Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Primary completion
- Nov 2004 (actual)
- First posted
- 14 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Sibutramine |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
- If the subject was female
Key exclusion criteria (25 listed)
- 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:
- Organic causes of obesity (e.g., hypothyroidism).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SibutramineAlso: ABT-991, Meridia, ReductilCapsules, Wk 0: 10mg, once daily; Wks 4-24: 10mg or 15mg, once daily, dosage escalation based upon investigator's assessment. | Drug | 1 |
| PlaceboCapsules, once daily | Drug | 2 |
Primary outcome
Change in bodyweight from baseline to final evaluation
Time frame: Wk 0, then, bi-weekly through duration of study
4 secondary outcomes
The percentage of change in body weight from baseline to final evaluation.
Time frame: Wk 0 and Wk 24
Total body fat mass, total body lean mass, percent of total body lean mass measurements (Bodystat® 1500)
Time frame: 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)
Time frame: Wk 0 and Wk 24
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2008.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sibutramine in people with Obesity, run by Abbott.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in bodyweight from baseline to final evaluation (time frame: Wk 0, then, bi-weekly through duration of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2008.