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

Organon

Status: Completed

Conditions: Hypercholesterolemia; Dyslipidemia

Study type: Observational

Funder types: Industry

Identifiers

NCT01414192

0653A-204

Details and patient eligibility

About

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.

Enrollment: 3,215 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

3,215 participants in 4 patient groups

Ezetimibe monotherapy without prior treatment

Description:

Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).

Ezetimibe monotherpay with prior treatment

Description:

Enrolled participants with prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).

Ezetimibe plus statin

Description:

Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin.

Ezetimibe/simvastatin

Description:

Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).