Ezetimibe/Simvastatin in Patients With Metabolic Syndrome (0653A-107)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00409773
First received: December 8, 2006
Last updated: September 16, 2014
Last verified: September 2014
Results First Received: June 16, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Hypercholesterolemia
Metabolic Syndrome
Interventions: Drug: ezetimibe (+) simvastatin
Drug: Comparator: atorvastatin calcium
Drug: Comparator: Placebo (unspecified)

  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

Phase III

First Patient In 06-Feb-2007:; Last Patient Last Visit 16-Jul-2008

110 centers worldwide (International, 12 countries)

Eligible patients include drug-naïve patients or patients rendered naïve with the appropriate prior washout at moderately high or high risk for coronary heart disease.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were randomized to 1 of 5 treatment groups: ezetimibe/simvastatin combination tablet or atorvastatin alone for 6 weeks stratified according to their baseline risk category stratum (high risk patients with atherosclerotic vascular disease or high risk patients without atherosclerotic vascular disease and moderately high risk patients).

Reporting Groups
  Description
Atorva 10 mg Atorvastatin 10 mg once daily for 6 weeks
EZ/Simva 10 mg/20 mg Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
Atorva 20mg Atorvastatin 20 mg once daily for 6 weeks
EZ/Simva 10 mg/40 mg Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
Atorva 40 mg Atorvastatin 40 mg once daily for 6 weeks

Participant Flow:   Overall Study
    Atorva 10 mg     EZ/Simva 10 mg/20 mg     Atorva 20mg     EZ/Simva 10 mg/40 mg     Atorva 40 mg  
STARTED     229     229     229     228     228  
COMPLETED     220     222     220     216     218  
NOT COMPLETED     9     7     9     12     10  
Adverse Event                 3                 4                 4                 2                 6  
Lost to Follow-up                 6                 1                 2                 3                 1  
Physician Decision                 0                 0                 0                 2                 0  
Protocol Violation                 0                 2                 3                 3                 1  
Withdrawal by Subject                 0                 0                 0                 2                 1  
Lack of Eligibility                 0                 0                 0                 0                 1  



  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
Atorva 10 mg Atorvastatin 10 mg once daily for 6 weeks
EZ/Simva 10 mg/20 mg Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
Atorva 20mg Atorvastatin 20 mg once daily for 6 weeks
EZ/Simva 10 mg/40 mg Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
Atorva 40 mg Atorvastatin 40 mg once daily for 6 weeks
Total Total of all reporting groups

Baseline Measures
    Atorva 10 mg     EZ/Simva 10 mg/20 mg     Atorva 20mg     EZ/Simva 10 mg/40 mg     Atorva 40 mg     Total  
Number of Participants  
[units: participants]
  229     229     229     228     228     1143  
Age  
[units: years]
Mean ( Full Range )
  59.7  
  ( 31 to 79 )  
  59.7  
  ( 32 to 78 )  
  58.2  
  ( 33 to 78 )  
  59.5  
  ( 28 to 80 )  
  58.4  
  ( 28 to 79 )  
  59.1  
  ( 28 to 80 )  
Gender  
[units: participants]
           
Female     97     87     106     104     104     498  
Male     132     142     123     124     124     645  
Race/Ethnicity, Customized  
[units: participants]
           
Asian     17     15     15     18     21     86  
Black     13     18     18     12     14     75  
Other     27     27     19     27     26     126  
White     172     169     177     171     167     856  



  Outcome Measures
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1.  Primary:   Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 6   [ Time Frame: Baseline and 6 Weeks ]

2.  Secondary:   Percent Change From Baseline in Total Cholesterol(mg/dL) at Week 6   [ Time Frame: Baseline and 6 Weeks ]

3.  Secondary:   Percent Change From Baseline in Triglyceride (TG) (mg/dL) at Week 6   [ Time Frame: Baseline and 6 Weeks ]

4.  Secondary:   Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 6   [ Time Frame: Baseline and 6 Weeks ]

5.  Secondary:   Percent Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6   [ Time Frame: Baseline and 6 Weeks ]

6.  Secondary:   Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 6   [ Time Frame: Baseline and 6 Weeks ]

7.  Secondary:   Percent Change From Baseline in Apolipoprotein- B (Apo-B) at Week 6   [ Time Frame: Baseline and 6 Weeks ]

8.  Secondary:   Percent Change From Baseline in Apolipoprotein-A1 (Apo-A1) at Week 6   [ Time Frame: Baseline and 6 Weeks ]

9.  Secondary:   Percent Change From Baseline in Total-Cholesterol: High Density Lipoprotein-Cholesterol (Total-C:HDL- C) at Week 6   [ Time Frame: Baseline and 6 Weeks ]

10.  Secondary:   Percent Change From Baseline in Low Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (LDL-C: HDL-C) at Week 6   [ Time Frame: Baseline and 6 Weeks ]

11.  Secondary:   Percent Change From Baseline in Apolipoprotein-B: Apolipoprotein-A1 (Apo-B:Apo-A1) at Week 6   [ Time Frame: Baseline and 6 weeks ]

12.  Secondary:   Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (Non-HDL-C:HDL-C) at Week 6   [ Time Frame: Baseline and 6 Weeks ]

13.  Secondary:   Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients With Atherosclerotic Vascular Disease (AVD)   [ Time Frame: Baseline and 6 Weeks ]

14.  Secondary:   Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients Without Atherosclerotic Vascular Disease (AVD)   [ Time Frame: Baseline and 6 Weeks ]

15.  Secondary:   Percent Change From Baseline in High-Sensitivity C-reactive (Hs-CRP) (mg/dL) at Week 6   [ Time Frame: Baseline and 6 Weeks ]


  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
15 patients were randomized but not treated. Since these patients were not treated no Adverse Event Data was collected.


  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: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided by Merck Sharp & Dohme Corp.

Publications automatically indexed to this study:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00409773     History of Changes
Other Study ID Numbers: 0653A-107, 2006_527
Study First Received: December 8, 2006
Results First Received: June 16, 2009
Last Updated: September 16, 2014
Health Authority: United States: Food and Drug Administration