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:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00234832
First received: September 13, 2005
Last updated: May 6, 2010
Last verified: May 2010
Results First Received: March 26, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Obesity
Interventions: Drug: Sibutramine hydrochloride
Drug: Placebo

  Participant Flow


  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Randomized Sibutramine Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
Randomized Placebo Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
Total Total of all reporting groups

Baseline Measures
    Randomized Sibutramine     Randomized Placebo     Total  
Number of Participants  
[units: participants]
  4906     4898     9804  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     3040     2997     6037  
>=65 years     1866     1901     3767  
Age  
[units: years]
Mean ± Standard Deviation
  63.2  ± 6.09     63.3  ± 6.15     63.2  ± 6.12  
Gender  
[units: participants]
     
Female     2099     2055     4154  
Male     2807     2843     5650  
Region of Enrollment  
[units: participants]
     
Europe     4160     4150     8310  
Australia     384     385     769  
Brazil     233     234     467  
Mexico     129     129     258  
Cardiovascular (CV) risk group status [1]
[units: Participants]
     
DM only     1207     1178     2385  
CV only     759     793     1552  
CV + DM     2906     2901     5807  
Unknown CV risk group status     34     26     60  
[1] Subjects were categorized at study entry into 1 of 3 prespecified CV risk groups: 1) diabetes mellitus (DM) only = history of type 2 DM with at least one other risk factor but no history of CV disease, 2) CV only = history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, but no history of type 2 DM with at least one other risk factor, and 3) CV + DM = history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, and a history of type 2 DM with at least one other risk factor.



  Outcome Measures
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1.  Primary:   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 ]

2.  Secondary:   Risk of Death From Any Cause (All-cause Mortality)   [ Time Frame: From randomization up to 6 years ]

3.  Secondary:   Risk of Experiencing a POE or a Revascularization Procedure   [ Time Frame: From randomization up to 6 years ]

4.  Secondary:   Risk of Experiencing a Nonfatal MI Included in the POE   [ Time Frame: From randomization up to 6 years ]

5.  Secondary:   Risk of Experiencing a Nonfatal Stroke Included in the POE   [ Time Frame: From randomization up to 6 years ]

6.  Secondary:   Risk of Experiencing a Resuscitated Cardiac Arrest Included in the POE   [ Time Frame: From randomization up to 6 years ]

7.  Secondary:   Risk of Experiencing Cardiovascular Death Included in the POE   [ Time Frame: From randomization up to 6 years ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Most subjects not indicated for sibutramine (sbt) due to CV disease. Long-term sbt use (6 yrs) regardless of weight loss, is inconsistent with label (limits use to 1-2 yrs & 5% weight loss). Trial lacked true placebo; all received Lead-in Period sbt.  


Results Point of Contact:  
Name/Title: Global Medical Services
Organization: Abbott
phone: 800-633-9110


No publications provided by Abbott

Publications automatically indexed to this study:

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