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A Long Term Study of Sibutramine and the Role of Obesity Management in Relation to Cardiovascular Disease in Overweight and Obese Patients (SCOUT)

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ClinicalTrials.gov Identifier: NCT00234832
Recruitment Status : Completed
First Posted : October 10, 2005
Results First Posted : April 15, 2010
Last Update Posted : May 11, 2010
Sponsor:
Information provided by:
Abbott

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE October 10, 2005
Results First Submitted Date March 26, 2010
Results First Posted Date April 15, 2010
Last Update Posted Date May 11, 2010
Study Start Date  ICMJE January 2003
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2010)
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 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 7, 2005)
Time from randomization to the first occurence of any of any CV Outcome Event.
Change History Complete list of historical versions of study NCT00234832 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2010)
  • Risk of Death From Any Cause (All-cause Mortality) [ Time Frame: From randomization up to 6 years ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    For each subject, the time to cardiovascular death included in the POE was evaluated using time-to-event analysis.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2005)
Time from randomization to onset of each of protocol specified events; All-cause Mortality.
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE A Long Term Study of Sibutramine and the Role of Obesity Management in Relation to Cardiovascular Disease in Overweight and Obese Patients
Official Title  ICMJE Sibutramine Cardiovascular Morbidity/Mortality Outcomes Study in Overweight or Obese Subjects at Risk of a Cardiovascular Event
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.

Study Type  ICMJE Interventional
Study Phase Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • 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:
    • ABT-991
    • sibutramine
    • Meridia
    • Reductil
  • 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.)
  • Drug: Sibutramine hydrochloride
    10 mg tablet QD during the 6-week Lead-in Period plus country-specific standard care for weight management
Study Arms
  • Experimental: Sibutramine
    Subjects were randomized to receive sibutramine 10 mg once daily (QD) during the Treatment Period after a 6-week Lead-in Period
    Intervention: Drug: Sibutramine hydrochloride
  • Placebo Comparator: Placebo
    Subjects were randomized to receive placebo QD during the Treatment Period after a 6-week Lead-in Period
    Intervention: Drug: Placebo
  • Experimental: Lead-in sibutramine
    All subjects received 10 mg sibutramine QD during a 6-week Lead-in Period
    Intervention: Drug: Sibutramine hydrochloride
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 26, 2010)
10777
Original Enrollment  ICMJE
 (submitted: October 7, 2005)
9000
Actual Study Completion Date November 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00234832
Other Study ID Numbers  ICMJE M01-392
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Cheryl Renz, MD, Abbott
Study Sponsor  ICMJE Abbott
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Cheryl Renz, MD Abbott
PRS Account Abbott
Verification Date May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP