Trial record 1 of 1 for:
scout meridia
A Long Term Study of Sibutramine and the Role of Obesity Management in Relation to Cardiovascular Disease in Overweight and Obese Patients (SCOUT)
This study has been completed.
Sponsor:
Abbott
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00234832
First received: September 13, 2005
Last updated: May 6, 2010
Last verified: May 2010
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Purpose
The purpose of the study was to determine the long-term effect of sibutramine treatment on cardiovascular outcomes in overweight and obese patients at risk of a cardiovascular event.
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity |
Drug: Sibutramine hydrochloride Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Sibutramine Cardiovascular Morbidity/Mortality Outcomes Study in Overweight or Obese Subjects at Risk of a Cardiovascular Event |
Resource links provided by NLM:
Further study details as provided by Abbott:
Primary Outcome Measures:
- Risk of Experiencing a Primary Outcome Event (POE) (i.e., Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, Resuscitated Cardiac Arrest, Cardiovascular [CV] Death) [ Time Frame: From randomization up to 6 years ] [ Designated as safety issue: Yes ]For each subject, POE status (with/without an event) and time to first occurrence of a POE using time-to-event analysis were evaluated. All POE confirmed by an independent adjudication committee were included in the analysis.
Secondary Outcome Measures:
- Risk of Death From Any Cause (All-cause Mortality) [ Time Frame: From randomization up to 6 years ] [ Designated as safety issue: Yes ]For each subject who died, the time to death was evaluated using time-to-event analysis.
- Risk of Experiencing a POE or a Revascularization Procedure [ Time Frame: From randomization up to 6 years ] [ Designated as safety issue: Yes ]This outcome includes nonfatal MI, nonfatal stroke, resuscitated cardiac arrest, CV death (including events such as fatal MI and fatal stroke), and any of the following revascularization procedures: percutaneous transluminal coronary angioplasty, coronary artery bypass graft, coronary artery stent placement, cardiac transplant, peripheral vascular bypass or angioplasty, and carotid endarterectomy. For each subject, the POE or revascularization status (yes/no) and time to first occurrence of an event using time-to-event analysis were evaluated.
- Risk of Experiencing a Nonfatal MI Included in the POE [ Time Frame: From randomization up to 6 years ] [ Designated as safety issue: Yes ]For each subject, the first occurrence of a nonfatal MI included in the POE was evaluated using time-to-event analysis.
- Risk of Experiencing a Nonfatal Stroke Included in the POE [ Time Frame: From randomization up to 6 years ] [ Designated as safety issue: Yes ]For each subject, the time to first occurrence of a nonfatal stroke included in the POE was evaluated using time-to-event analysis.
- Risk of Experiencing a Resuscitated Cardiac Arrest Included in the POE [ Time Frame: From randomization up to 6 years ] [ Designated as safety issue: Yes ]For each subject, the time to first occurrence of a resuscitated cardiac arrest included in the POE was evaluated using time-to-event analysis.
- Risk of Experiencing Cardiovascular Death Included in the POE [ Time Frame: From randomization up to 6 years ] [ Designated as safety issue: Yes ]For each subject, the time to cardiovascular death included in the POE was evaluated using time-to-event analysis.
| Enrollment: | 10777 |
| Study Start Date: | January 2003 |
| Study Completion Date: | November 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Sibutramine
Subjects were randomized to receive sibutramine 10 mg once daily (QD) during the Treatment Period after a 6-week Lead-in Period
|
Drug: Sibutramine hydrochloride
One 10 mg tablet QD plus country-specific standard care for weight management. (During the Treatment Period, the dose could have been titrated up to 15 mg at the investigator's discretion.)
Other Names:
|
|
Placebo Comparator: Placebo
Subjects were randomized to receive placebo QD during the Treatment Period after a 6-week Lead-in Period
|
Drug: Placebo
1 tablet QD plus country-specific standard care for weight management (During the Treatment Period, the dose could have been titrated up to 15 mg at the investigator's discretion.)
Other Name: Placebo
|
|
Experimental: Lead-in sibutramine
All subjects received 10 mg sibutramine QD during a 6-week Lead-in Period
|
Drug: Sibutramine hydrochloride
10 mg tablet QD during the 6-week Lead-in Period plus country-specific standard care for weight management
|
Detailed Description:
The study consisted of 4 periods: 1) a Screening Period of approximately 2 weeks; 2) a 6-week Lead-in Period, during which subjects received single-blind sibutramine and country-specific standard of care for weight management. Subjects who discontinued study drug treatment during the Lead-in Period were not randomized and did not participate in the double-blind Treatment Period or the Follow-up Period; 3) a double-blind Treatment Period in which subjects were randomized to 1 of the 2 treatment groups and were followed until the study ended; and 4) a double-blind Follow-up Period, during which randomized subjects who discontinued study drug were followed until the study ended. The Randomization Phase consisted of the double-blind Treatment Period and the double-blind Follow-up Period. Subjects received country-specific standard of care for weight management during the Randomization Phase.
An independent events adjudication committee evaluated all potential cardiovascular outcome events and confirmed the outcome events and time of onset to be included in the statistical analyses.
Eligibility| Ages Eligible for Study: | 55 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subject's body mass index (BMI) was >= 27 kg/m(2) and <= 45 kg/m(2) or their BMI was >= 25 kg/m(2) and < 27 kg/m(2) with waist circumference of >= 102 cm in males or >= 88 cm in females.
Medical history positive for:
- Preexisting cardiovascular disease (i.e., coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease) and/or
- Type 2 diabetes mellitus with at least 1 other risk factor (i.e., dyslipidemia, controlled hypertension, current smoker, or diabetic nephropathy with evidence of microalbuminuria)
Exclusion Criteria:
- History of recent myocardial infarction.
- Heart failure symptoms greater than New York Heart Association Functional Class II.
- Hemodynamically significant valvular or left ventricular (LV) tract obstruction.
Subjects without a pacemaker and with any of the following:
- Sinus bradycardia (< 50 bpm)
- Sick sinus syndrome
- Atrioventricular block of more than 1st degree
- Mean sitting systolic blood pressure (SBP) > 160 mmHg. Mean sitting diastolic blood pressure (DBP) > 100 mmHg. Mean sitting heart rate (HR) > 100 bpm.
- Syncopal episodes presumed to be due to uncontrolled life-threatening arrhythmias.
- Planned cardiac surgery or coronary angioplasty within 6 months of screening.
- History of recent non-hemorrhagic stroke or transient ischemic attack (TIA), history of hemorrhagic stroke.
- Hyperthyroidism.
- Known chronic liver disease or endstage renal disease.
- Severe, symptomatic benign prostatic hyperplasia which may require surgery.
- Known pheochromocytoma, history of narrow angle glaucoma, Gilles de la Tourette syndrome, history of seizures, history of bariatric or abdominal obesity surgery (excluding liposuction).
- Concomitant use of monoamine oxidase inhibitors or drugs that increase levels of serotonin in the brain.
- Treated hypertension stabilized for less than 3 months.
- Inability to perform regular physical activity.
Contacts and Locations More Information
Additional Information:
No publications provided by Abbott
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Cheryl Renz, MD, Abbott |
| ClinicalTrials.gov Identifier: | NCT00234832 History of Changes |
| Other Study ID Numbers: | M01-392 |
| Study First Received: | September 13, 2005 |
| Results First Received: | March 26, 2010 |
| Last Updated: | May 6, 2010 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Abbott:
|
Obesity Sibutramine |
Additional relevant MeSH terms:
|
Sibutramine Cardiovascular Diseases Obesity Overweight Overnutrition Nutrition Disorders Body Weight Signs and Symptoms |
Appetite Depressants Anti-Obesity Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Antidepressive Agents Psychotropic Drugs |
ClinicalTrials.gov processed this record on May 22, 2013