A Study to Assess the Cholesterol Lowering Effect of Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Elderly Patients With High Cholesterol at High or Moderately High Risk for Coronary Heart Disease (0653A-128)

This study has been completed.
Sponsor:
Collaborator:
Merck Shering-Plough JV Study
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00535405
First received: September 25, 2007
Last updated: April 29, 2014
Last verified: April 2014
Results First Received: April 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: Hypercholesterolemia
Interventions: Drug: Atorvastatin 10 mg
Drug: Ezetimibe 10 mg/simvastatin 20 mg
Drug: Atorvastatin 20 mg
Drug: Ezetimibe 10 mg/simvastatin 40 mg
Drug: Atorvastatin 40 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

Phase III

First Patient In 08-Nov-2007; Last Patient Last Visit 23-Mar-2009

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 65 years and older.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study evaluated patients ≥ 65 years of age at moderately high or high risk for Coronary Heart Disease (CHD), with or without atherosclerotic vascular disease. The study was a 3-week single-blind placebo run-in period and a 12-week active treatment period where patients were equally randomized to one of 5 treatment groups for 12 weeks

Reporting Groups
  Description
Atorvastatin 10 mg Atorvastatin (Atorva) 10 mg once daily for 12 weeks
Ezetimibe 10 mg/Simvastatin 20 mg Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks
Atorvastatin 20 mg Atorvastatin 20 mg once daily for 12 weeks
Ezetimibe 10 mg/Simvastatin 40 mg Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks
Atorva 40 mg Atorvastatin 40 mg once daily for 12 weeks

Participant Flow:   Overall Study
    Atorvastatin 10 mg     Ezetimibe 10 mg/Simvastatin 20 mg     Atorvastatin 20 mg     Ezetimibe 10 mg/Simvastatin 40 mg     Atorva 40 mg  
STARTED     257     259     259     257     257  
COMPLETED     240     233     241     235     241  
NOT COMPLETED     17     26     18     22     16  
Adverse Event                 6                 8                 3                 8                 6  
Lost to Follow-up                 1                 3                 3                 2                 1  
Physician Decision                 3                 2                 0                 1                 1  
Protocol Violation                 2                 2                 2                 1                 0  
Withdrawal by Subject                 5                 11                 10                 10                 8  



  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
Atorvastatin 10 mg Atorvastatin (Atorva) 10 mg once daily for 12 weeks
Ezetimibe 10 mg/Simvastatin 20 mg Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks
Atorvastatin 20 mg Atorvastatin 20 mg once daily for 12 weeks
Ezetimibe 10 mg/Simvastatin 40 mg Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks
Atorva 40 mg Atorvastatin 40 mg once daily for 12 weeks
Total Total of all reporting groups

Baseline Measures
    Atorvastatin 10 mg     Ezetimibe 10 mg/Simvastatin 20 mg     Atorvastatin 20 mg     Ezetimibe 10 mg/Simvastatin 40 mg     Atorva 40 mg     Total  
Number of Participants  
[units: participants]
  257     259     259     257     257     1289  
Age  
[units: years]
Mean ( Full Range )
  72.1  
  ( 65 to 94 )  
  71.8  
  ( 65 to 95 )  
  71.7  
  ( 65 to 90 )  
  72.2  
  ( 65 to 96 )  
  72.1  
  ( 65 to 88 )  
  72.0  
  ( 65 to 96 )  
Gender  
[units: participants]
           
Female     172     146     175     153     163     809  
Male     85     113     84     104     94     480  
Race/Ethnicity, Customized  
[units: participants]
           
Asian     10     6     12     8     10     46  
Black     2     2     8     6     9     27  
Other     21     27     30     29     28     135  
White     224     224     209     214     210     1081  



  Outcome Measures
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1.  Primary:   Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12   [ Time Frame: Baseline and 12 weeks ]

2.  Secondary:   Percentage of Patients Who Achieved LDL-C <70 mg/dL at Week 12   [ Time Frame: 12 weeks ]

3.  Secondary:   Percentage of Patients Without Atherosclerosis Vascular Disease (AVD) Who Achieved LDL-C <100 mg/dL or Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12   [ Time Frame: 12 Weeks ]

4.  Secondary:   Percentage of Patients Who Achieved LDL-C <100 mg/dL at Week 12   [ Time Frame: 12 Weeks ]

5.  Secondary:   Percentage of Patients With High Risk for CHD Who Achieved LDL-C <70 mg/dL at Week 12   [ Time Frame: 12 Weeks ]

6.  Secondary:   Percentage of Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12   [ Time Frame: 12 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
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  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 of Results:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00535405     History of Changes
Other Study ID Numbers: 0653A-128, 2007_588
Study First Received: September 25, 2007
Results First Received: April 26, 2010
Last Updated: April 29, 2014
Health Authority: United States: Food and Drug Administration