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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01414192
Recruitment Status : Completed
First Posted : August 11, 2011
Results First Posted : January 8, 2016
Last Update Posted : July 2, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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.

Condition or disease
Dyslipidemia Hypercholesterolemia

Study Type : Observational
Actual Enrollment : 3215 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Model-Observation Bridging Study (MOBS) for Ezetrol® and Inegy®
Actual Study Start Date : November 15, 2008
Actual Primary Completion Date : September 15, 2014
Actual Study Completion Date : September 15, 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Ezetimibe

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.
Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The resident population of Continental France being treated for hypercholesterolemia in a general practice setting.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01414192

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Director Merck Sharp & Dohme Corp.

Study Data/Documents: CSR Synopsis  This link exits the site

Publications of Results:
Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT01414192     History of Changes
Other Study ID Numbers: 0653A-204
First Posted: August 11, 2011    Key Record Dates
Results First Posted: January 8, 2016
Last Update Posted: July 2, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents