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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT01414192
First received: August 9, 2011
Last updated: September 7, 2011
Last verified: September 2011
History of Changes
  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:

MedlinePlus related topics: Cholesterol Statins
Drug Information available for: Ezetimibe
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in LDL-C levels [ Time Frame: From baseline up to 4 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Average duration (in days) of treatment with Ezetrol® [ Time Frame: From baseline up to 4 years ] [ Designated as safety issue: No ]
  • Average duration (in days) of treatment with Inegy® [ Time Frame: From baseline up to 4 years ] [ Designated as safety issue: No ]
  • Average duration (in days) of treatment with other statins [ Time Frame: From baseline up to 4 years ] [ Designated as safety issue: No ]
  • Number of participants who discontinued study drug [ Time Frame: From baseline up to 4 years ] [ Designated as safety issue: No ]
  • Number of participant deaths [ Time Frame: From baseline up to 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 3000
Study Start Date: November 2008
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Participants treated with ezetimibe monotherapy
Participants in the French population treated for hypercholesterolemia with ezetimibe alone (Ezetrol®)
Participants treated with ezetimibe + a statin
Participants in the French population treated for hypercholesterolemia with ezetimibe + a statin drug
Participants treated with ezetimibe + simvastatin fixed dose
Participants in the French population treated for hypercholesterolemia with ezetimibe + simvastatin fixed dose (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
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT01414192     History of Changes
Other Study ID Numbers: MK-0653A-204
Study First Received: August 9, 2011
Last Updated: September 7, 2011
Health Authority: France: Haute Autorité de Santé Transparency Commission

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

ClinicalTrials.gov processed this record on May 19, 2013