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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: November 6, 2016
Last verified: November 2016
August 9, 2011
November 6, 2016
November 2008
September 2014   (Final data collection date for primary outcome measure)
Rate of Cardiovascular (CV) Events [ Time Frame: up to 48 months ]
Number of participants who experienced myocardial infarction, acute coronary syndrome, unstable angina, ischemic stroke, revascularization procedure, fatal stroke, and/or sudden death was recorded. The number of events was divided by the total number of patient-years calculated for each treatment group to produce the rate of CV events per 1000 patient years.
Number of participants with cardiovascular (CV) events (myocardial infarction, acute coronary syndrome, unstable angina, ischemic stroke, revascularization procedure, fatal stroke, and sudden death) [ Time Frame: From baseline up to 4 years ]
Complete list of historical versions of study NCT01414192 on ClinicalTrials.gov Archive Site
  • Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Levels at 12 Months [ Time Frame: Baseline and Month 12 ]
    LDL-C levels at baseline and after 12 months of treatment were compared and the percentage change was recorded. In the model, it is assumed that the 5th and 95th percentiles represent the minimum and maximum effect of treatment, respectively.
  • Percentage of Participants With CV Risk Factors [ Time Frame: At enrollment (baseline) ]
    Enrolled participants' data were reviewed for presence of CV risk factors that included smoking, alcohol & substance abuse, high blood pressure, Type 1 and Type 2 diabetes mellitus, cholesterol level, hypertriglyceridemia, body mass index, cardiovascular disease history, family history of early cardiovascular disease. The sum of all risk factors was tabulated for each participant and totals were summarized by group.
  • Percentage of Participants Who Continued Treatment for 12, 24, 36, and 48 Months [ Time Frame: up to 48 months ]
    Participants' data reviewed and the number of participants who had continued treatment for 12, 24, 36, and 48 months was recorded.
  • Percentage of Participants With at Least 1 Discontinuation of Study Drug [ Time Frame: up to 48 months ]
    The percentage of participants who stopped study drug at least once during the study period was recorded and summarized.
  • Mortality Rate [ Time Frame: up to 48 months ]
    The number of participants who died from any cause was recorded. The number of deaths was then extrapolated to produce the number of deaths per 100,000 patient-years.
  • Change from baseline in LDL-C levels [ Time Frame: From baseline up to 4 years ]
  • Number of participants with CV risk factors (including age, gender, lipids, hypertension, diabetes, body mass index, personal/family history of CV events, smoking, alcohol/substance dependence/abuse, comorbidities, education, occupational status) [ Time Frame: From baseline up to 4 years ]
  • Average duration (in days) of treatment with Ezetrol® [ Time Frame: From baseline up to 4 years ]
  • Average duration (in days) of treatment with Inegy® [ Time Frame: From baseline up to 4 years ]
  • Average duration (in days) of treatment with other statins [ Time Frame: From baseline up to 4 years ]
  • Number of participants who discontinued study drug [ Time Frame: From baseline up to 4 years ]
  • Number of participant deaths [ Time Frame: From baseline up to 4 years ]
Not Provided
Not Provided
 
A Study to Design a Model Cohort for Analysis of Dyslipidemia (MK-0653A-204)
Model-Observation Bridging Study (MOBS) for Ezetrol® and Inegy®
This study is being done to provide valid data on the evolution of a cohort of French participants treated with ezetimibe, alone or in combination with a statin, to be used in simulation models for cardiovascular disease (CVD). Patterns of drug use, evolution of risk factors for CVD, cardiovascular morbidity and mortality, and goal attainment in low density lipoprotein cholesterol (LDL-C) levels over time will be analyzed.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
The resident population of Continental France being treated for hypercholesterolemia in a general practice setting.
  • Dyslipidemia
  • Hypercholesterolemia
Not Provided
  • 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.
  • Ezetimibe/simvastatin
    Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).
Ferrières J, Dallongeville J, Rossignol M, Bénichou J, Caro JJ, Getsios D, Hernandez L, Abenhaim L, Grimaldi-Bensouda L. Model-observational bridging study on the effectiveness of ezetimibe on cardiovascular morbidity and mortality in France: A population-based study. J Clin Lipidol. 2016 Nov - Dec;10(6):1379-1388. doi: 10.1016/j.jacl.2016.08.015. Epub 2016 Sep 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3215
September 2014
September 2014   (Final data collection date for primary outcome measure)

Inclusion criteria:

  • Resident of Continental France
  • Treated by ezetimibe either as monotherapy (Ezetrol®), or co-administered with a statin or administered in a fixed combination of ezetimibe and simvastatin (Inegy®)
  • Incident treatment with ezetimibe at the time of recruitment into the study

Exclusion criteria:

  • Unlikely to be followed-up for the next 6 months after recruitment due to a planned change of residence
  • Participating in a clinical trial
  • Unable to read the information letter in French and/or unable to participate in the telephone interview in French
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01414192
0653A-204
No
Not Provided
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Director Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP