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
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 10777 subjects enrolled into the study, 33 were not treated with Lead-in Period sibutramine. Of the 10744 subjects who took at least 1 dose of Lead-in Period sibutramine, 939 were not randomized. One of the remaining 9805 subjects was not dispensed randomized study drug and was not included in the intent-to-treat population (N = 9804).

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.

Participant Flow:   Overall Study
    Randomized Sibutramine     Randomized Placebo  
STARTED     4906 [1]   4898 [1]
COMPLETED     3890 [2]   3902 [2]
NOT COMPLETED     1016     996  
[1] Subjects completed the 6-week Lead-in Period and were dispensed randomized study drug.
[2] Subjects completed the Randomization Phase.



  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 ]
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Measure Type Secondary
Measure Title Risk of Death From Any Cause (All-cause Mortality)
Measure 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  
Safety Issue Yes  

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.
Analysis based on ITT population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized.

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.

Measured Values
    Randomized Sibutramine     Randomized Placebo  
Number of Participants Analyzed  
[units: participants]
  4906     4898  
Risk of Death From Any Cause (All-cause Mortality)  
[units: Participants]
  418     404  


Statistical Analysis 1 for Risk of Death From Any Cause (All-cause Mortality)
Groups [1] All groups
Method [2] Log Rank
P Value [3] 0.543
Cox Proportional Hazard [4] 1.043
95% Confidence Interval ( 0.910 to 1.196 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



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


  Limitations and Caveats
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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.


  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.


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