A Study to Design a Model Cohort for Analysis of Dyslipidemia (MK-0653A-204) (MOBS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01414192
First received: August 9, 2011
Last updated: December 2, 2015
Last verified: November 2015
Results First Received: September 14, 2015  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Dyslipidemia
Hypercholesterolemia

  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
Data was provided by French physicians for participants who were being administered Ezetrol® monotherapy, or Ezetrol® coadministered with a statin, or Inegy® (a fixed-dose combination of ezetimibe and simvastatin.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All participants who met inclusion criteria and contributed to at least one type of follow-up data in the form of an interview or physician questionnaire were included in the study.

Reporting Groups
  Description
Ezetimibe Monotherapy Without Prior Treatment Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
Ezetimibe Monotherpay With Prior Treatment Enrolled participants with prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
Ezetimibe Plus Statin Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin
Ezetimibe/Simvastatin Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).

Participant Flow:   Overall Study
    Ezetimibe Monotherapy Without Prior Treatment     Ezetimibe Monotherpay With Prior Treatment     Ezetimibe Plus Statin     Ezetimibe/Simvastatin  
STARTED     490     575     424     1726  
COMPLETED     490     575     424     1726  
NOT COMPLETED     0     0     0     0  



  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 Monotherapy Without Prior Treatment Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
Ezetimibe Monotherpay With Prior Treatment Enrolled participants with prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
Ezetimibe Plus Statin Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin
Ezetimibe/Simvastatin Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).
Total Total of all reporting groups

Baseline Measures
    Ezetimibe Monotherapy Without Prior Treatment     Ezetimibe Monotherpay With Prior Treatment     Ezetimibe Plus Statin     Ezetimibe/Simvastatin     Total  
Number of Participants  
[units: participants]
  490     575     424     1726     3215  
Age  
[units: years]
Mean (Standard Deviation)
  60.3  (11.5)     63.3  (9.7)     60.8  (10.8)     61.4  (10.6)     61.5  (10.7)  
Gender  
[units: Participants]
         
Female     283     284     164     728     1459  
Male     207     291     260     998     1756  



  Outcome Measures
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1.  Primary:   Rate of Cardiovascular (CV) Events   [ Time Frame: up to 48 months ]

2.  Secondary:   Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Levels at 12 Months   [ Time Frame: Baseline and Month 12 ]

3.  Secondary:   Percentage of Participants With CV Risk Factors   [ Time Frame: At enrollment (baseline) ]

4.  Secondary:   Percentage of Participants Who Continued Treatment for 12, 24, 36, and 48 Months   [ Time Frame: up to 48 months ]

5.  Secondary:   Percentage of Participants With at Least 1 Discontinuation of Study Drug   [ Time Frame: up to 48 months ]

6.  Secondary:   Mortality Rate   [ Time Frame: up to 48 months ]


  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 NOT 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.


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



Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01414192     History of Changes
Other Study ID Numbers: 0653A-204
Study First Received: August 9, 2011
Results First Received: September 14, 2015
Last Updated: December 2, 2015
Health Authority: France: Haute Autorité de Santé Transparency Commission