Back to resultsA Long Term Study of Sibutramine and the Role of Obesity Management in Relation to Cardiovascular Disease in Overweight and Obese Patients (SCOUT)
Primary Purpose
Obesity
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Sibutramine hydrochloride
Placebo
Sibutramine hydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity, Sibutramine
Eligibility 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.
Sites / Locations
- Global Medical Services
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Experimental
Arm Label
Sibutramine
Placebo
Lead-in sibutramine
Arm Description
Subjects were randomized to receive sibutramine 10 mg once daily (QD) during the Treatment Period after a 6-week Lead-in Period
Subjects were randomized to receive placebo QD during the Treatment Period after a 6-week Lead-in Period
All subjects received 10 mg sibutramine QD during a 6-week Lead-in Period
Outcomes
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)
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)
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
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
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
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
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
For each subject, the time to cardiovascular death included in the POE was evaluated using time-to-event analysis.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00234832
Brief Title
A Long Term Study of Sibutramine and the Role of Obesity Management in Relation to Cardiovascular Disease in Overweight and Obese Patients
Acronym
SCOUT
Official Title
Sibutramine Cardiovascular Morbidity/Mortality Outcomes Study in Overweight or Obese Subjects at Risk of a Cardiovascular Event
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Abbott
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Sibutramine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
10777 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sibutramine
Arm Type
Experimental
Arm Description
Subjects were randomized to receive sibutramine 10 mg once daily (QD) during the Treatment Period after a 6-week Lead-in Period
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects were randomized to receive placebo QD during the Treatment Period after a 6-week Lead-in Period
Arm Title
Lead-in sibutramine
Arm Type
Experimental
Arm Description
All subjects received 10 mg sibutramine QD during a 6-week Lead-in Period
Intervention Type
Drug
Intervention Name(s)
Sibutramine hydrochloride
Other Intervention Name(s)
ABT-991, sibutramine, Meridia, Reductil
Intervention Description
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.)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.)
Intervention Type
Drug
Intervention Name(s)
Sibutramine hydrochloride
Intervention Description
10 mg tablet QD during the 6-week Lead-in Period plus country-specific standard care for weight management
Primary Outcome Measure Information:
Title
Risk of Experiencing a Primary Outcome Event (POE) (i.e., Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, Resuscitated Cardiac Arrest, Cardiovascular [CV] Death)
Description
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.
Time Frame
From randomization up to 6 years
Secondary Outcome Measure Information:
Title
Risk of Death From Any Cause (All-cause Mortality)
Description
For each subject who died, the time to death was evaluated using time-to-event analysis.
Time Frame
From randomization up to 6 years
Title
Risk of Experiencing a POE or a Revascularization Procedure
Description
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.
Time Frame
From randomization up to 6 years
Title
Risk of Experiencing a Nonfatal MI Included in the POE
Description
For each subject, the first occurrence of a nonfatal MI included in the POE was evaluated using time-to-event analysis.
Time Frame
From randomization up to 6 years
Title
Risk of Experiencing a Nonfatal Stroke Included in the POE
Description
For each subject, the time to first occurrence of a nonfatal stroke included in the POE was evaluated using time-to-event analysis.
Time Frame
From randomization up to 6 years
Title
Risk of Experiencing a Resuscitated Cardiac Arrest Included in the POE
Description
For each subject, the time to first occurrence of a resuscitated cardiac arrest included in the POE was evaluated using time-to-event analysis.
Time Frame
From randomization up to 6 years
Title
Risk of Experiencing Cardiovascular Death Included in the POE
Description
For each subject, the time to cardiovascular death included in the POE was evaluated using time-to-event analysis.
Time Frame
From randomization up to 6 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheryl Renz, MD
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Global Medical Services
City
North Chicago
State/Province
Illinois
ZIP/Postal Code
60064
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24534073
Citation
Jorgensen ME, Torp-Pedersen C, Finer N, Caterson I, James WP, Legler UF, Andersson C. Association between serum bilirubin and cardiovascular disease in an overweight high risk population from the SCOUT trial. Nutr Metab Cardiovasc Dis. 2014 Jun;24(6):656-62. doi: 10.1016/j.numecd.2013.12.009. Epub 2014 Jan 18.
Results Reference
derived
PubMed Identifier
24406481
Citation
Seimon RV, Espinoza D, Ivers L, Gebski V, Finer N, Legler UF, Sharma AM, James WP, Coutinho W, Caterson ID. Changes in body weight and blood pressure: paradoxical outcome events in overweight and obese subjects with cardiovascular disease. Int J Obes (Lond). 2014 Sep;38(9):1165-71. doi: 10.1038/ijo.2014.2. Epub 2014 Jan 10.
Results Reference
derived
PubMed Identifier
20818901
Citation
James WP, Caterson ID, Coutinho W, Finer N, Van Gaal LF, Maggioni AP, Torp-Pedersen C, Sharma AM, Shepherd GM, Rode RA, Renz CL; SCOUT Investigators. Effect of sibutramine on cardiovascular outcomes in overweight and obese subjects. N Engl J Med. 2010 Sep 2;363(10):905-17. doi: 10.1056/NEJMoa1003114.
Results Reference
derived
PubMed Identifier
20184783
Citation
Weeke P, Andersson C, Fosbol EL, Brendorp B, Kober L, Sharma AM, Finer N, James PT, Caterson ID, Rode RA, Torp-Pedersen C. The weight lowering effect of sibutramine and its impact on serum lipids in cardiovascular high risk patients with and without type 2 diabetes mellitus - an analysis from the SCOUT lead-in period. BMC Endocr Disord. 2010 Feb 26;10:3. doi: 10.1186/1472-6823-10-3.
Results Reference
derived
PubMed Identifier
19828038
Citation
Andersson C, Weeke P, Brendorp B, Kober L, Fosbol EL, Sharma AM, Finer N, Caterson ID, Rode RA, James PT, Torp-Pedersen C. Differential changes in serum uric acid concentrations in sibutramine promoted weight loss in diabetes: results from four weeks of the lead-in period of the SCOUT trial. Nutr Metab (Lond). 2009 Oct 14;6:42. doi: 10.1186/1743-7075-6-42.
Results Reference
derived
Learn more about this trial
A Long Term Study of Sibutramine and the Role of Obesity Management in Relation to Cardiovascular Disease in Overweight and Obese Patients
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