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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 2, 2015
Last verified: September 2015
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 
Overall Participants Analyzed 
[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: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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 2, 2015
Health Authority: United States: Food and Drug Administration