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 (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01414192
First received: August 9, 2011
Last updated: January 22, 2014
Last verified: January 2014

August 9, 2011
January 22, 2014
November 2008
March 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01414192 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
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
  • 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®)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
3202
March 2014
March 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01414192
0653A-204
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
January 2014

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