Ezetimibe/Simvastatin (MK-0653A) Versus Rosuvastatin Versus Doubling Statin Dose in Participants With Cardiovascular Disease and Diabetes Mellitus (MK-0653A-133)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00862251
First received: March 12, 2009
Last updated: March 26, 2012
Last verified: March 2012
Results First Received: February 23, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Cardiovascular Disorder
Diabetes Mellitus
Interventions: Drug: ezetimibe (+) simvastatin
Drug: simvastatin 40 mg or atorvastatin 20 mg
Drug: Rosuvastatin
Drug: atorvastatin 10 mg or simvastatin 20 mg

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Ezetimibe/Simvastatin Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
Doubling Statin Dose simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
Rosuvastatin Rosuvastatin 10 mg tablets, taken once daily for six weeks.

Participant Flow:   Overall Study
    Ezetimibe/Simvastatin     Doubling Statin Dose     Rosuvastatin  
STARTED     322     162     324  
COMPLETED     303     157     315  
NOT COMPLETED     19     5     9  
Adverse Event                 8                 3                 1  
Lost to Follow-up                 0                 0                 1  
Protocol Violation                 2                 0                 1  
Withdrawal by Subject                 9                 2                 6  



  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.
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Reporting Groups
  Description
Ezetimibe/Simvastatin Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
Doubling Statin Dose simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
Rosuvastatin Rosuvastatin 10 mg tablets, taken once daily for six weeks.
Total Total of all reporting groups

Baseline Measures
    Ezetimibe/Simvastatin     Doubling Statin Dose     Rosuvastatin     Total  
Number of Participants  
[units: participants]
  322     162     324     808  
Age  
[units: years]
Mean ± Standard Deviation
  64.1  ± 8.8     64.7  ± 8.3     63.6  ± 8.4     64.0  ± 8.5  
Gender  
[units: participants]
       
Female     162     82     142     386  
Male     160     80     182     422  



  Outcome Measures
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1.  Primary:   Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Statin (Simvastatin or Atorvastatin).   [ Time Frame: Baseline and Week 6 ]

2.  Secondary:   In Participants Treated With Simvastatin at Baseline, Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Simvastatin   [ Time Frame: Baseline and Week 6 ]

3.  Secondary:   In Participants Treated With Atorvastatin at Baseline, Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Atorvastatin   [ Time Frame: Baseline and Week 6 ]

4.  Secondary:   Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Switching Treatment to Rosuvastatin   [ Time Frame: Baseline and Week 6 ]

5.  Secondary:   Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L)   [ Time Frame: Week 6 ]

6.  Secondary:   In Participants Treated With Simvastatin at Baseline, Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L)   [ Time Frame: Week 6 ]

7.  Secondary:   In Participants Treated With Atorvastatin at Baseline, Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L)   [ Time Frame: Week 6 ]

8.  Secondary:   Percent Change From Baseline in Total Cholesterol (TC)   [ Time Frame: Baseline and Week 6 ]

9.  Secondary:   Percent Change From Baseline in Triglycerides   [ Time Frame: Baseline and Week 6 ]

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

11.  Secondary:   Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)   [ Time Frame: Baseline and Week 6 ]

12.  Secondary:   Percent Change From Baseline in LDL-C/HDL-C Ratio   [ Time Frame: Baseline and Week 6 ]

13.  Secondary:   Percent Change From Baseline in TC/HDL-C Ratio   [ Time Frame: Baseline and Week 6 ]

14.  Secondary:   Percent Change From Baseline in Non-HDL-C/HDL-C Ratio   [ Time Frame: Baseline and Week 6 ]

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

16.  Secondary:   Percent Change From Baseline Apolipoprotein A-I (Apo A-I)   [ Time Frame: Baseline and Week 6 ]

17.  Secondary:   Percent Change From Baseline in Apo B/Apo A-I Ratio   [ Time Frame: Baseline and Week 6 ]

18.  Secondary:   Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP)   [ Time Frame: Baseline and Week 6 ]


  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
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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: NCT00862251     History of Changes
Other Study ID Numbers: MK-0653A-133, 2009_559
Study First Received: March 12, 2009
Results First Received: February 23, 2012
Last Updated: March 26, 2012
Health Authority: United States: Food and Drug Administration