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

May 6, 2010 updated by: Abbott

Sibutramine Cardiovascular Morbidity/Mortality Outcomes Study in Overweight or Obese Subjects at Risk of a Cardiovascular Event

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

10777

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • North Chicago, Illinois, United States, 60064
        • Global Medical Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • ABT-991
  • Meridia
  • Reductil
  • sibutramine
Drug: Sibutramine hydrochloride
10 mg tablet QD during the 6-week Lead-in Period plus country-specific standard care for weight management
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.)
Experimental: Lead-in sibutramine
All subjects received 10 mg sibutramine QD during 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:
  • ABT-991
  • Meridia
  • Reductil
  • sibutramine
Drug: Sibutramine hydrochloride
10 mg tablet QD during the 6-week Lead-in Period plus country-specific standard care for weight management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From randomization up to 6 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From randomization up to 6 years
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.
From randomization up to 6 years
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.
From randomization up to 6 years
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.
From randomization up to 6 years
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.
From randomization up to 6 years
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.
From randomization up to 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Investigators

  • Study Director: Cheryl Renz, MD, Abbott

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

October 7, 2005

First Posted (Estimate)

October 10, 2005

Study Record Updates

Last Update Posted (Estimate)

May 11, 2010

Last Update Submitted That Met QC Criteria

May 6, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M01-392

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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