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Completed

NCT Number: NCT01414192

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

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.

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Key information

Conditions

Dyslipidemia Dyslipidemias Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

Model-Observation Bridging Study (MOBS) for Ezetrol® and Inegy®

Acronym: MOBS

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Aug 11, 2011
Registry last updated
Sep 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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