N/A
N=3,215
A Study to Design a Model Cohort for Analysis of Dyslipidemia (MK-0653A-204)
Dyslipidemia · Hypercholesterolemia
Bottom Line
View on ClinicalTrials.gov: NCT01414192 ↗Enrolled (actual)
3,215
Serious AEs
—
Results posted
Jan 2016
Primary outcome: Primary: Rate of Cardiovascular (CV) Events — 7.91; 10.79; 12.77; 13.4 Events per 1000 patient-years
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Organon and Co
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Cardiovascular (CV) Events |
7.91; 10.79; 12.77; 13.4 | — |
| SECONDARY Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Levels at 12 Months |
-22.4; -7.1; -30.7 | — |
| SECONDARY Percentage of Participants With CV Risk Factors |
19.0; 15.0; 11.3; 11.2; 29.0; 20.9 | — |
| SECONDARY Percentage of Participants Who Continued Treatment for 12, 24, 36, and 48 Months |
28.0; 14.6; 57.4; 27.1; 14.3; 58.6 | — |
| SECONDARY Percentage of Participants With at Least 1 Discontinuation of Study Drug |
15.8; 13.4; 10.1; 11.8 | — |
| SECONDARY Mortality Rate |
506.54; 689.66; 817.81; 761.77 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01414192). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.