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
  Purpose
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
Dyslipidemia
Hypercholesterolemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Model-Observation Bridging Study (MOBS) for Ezetrol® and Inegy®

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Rate of Cardiovascular (CV) Events [ Time Frame: up to 48 months ] [ Designated as safety issue: No ]
    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:
  • Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Levels at 12 Months [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 3215
Study Start Date: November 2008
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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®).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01414192

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

No publications provided

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

Additional relevant MeSH terms:
Dyslipidemias
Hypercholesterolemia
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Ezetimibe
Anticholesteremic Agents
Antimetabolites
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2016