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

Hypercholesterolemia Clinical Trial

— MOBS  

Official title:

Model-Observation Bridging Study (MOBS) for Ezetrol® and Inegy®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01414192
• Other study ID #: 0653A-204
• Status: Completed
• Start date: November 15, 2008
• Est. completion date: September 15, 2014

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3215
• Est. completion date: September 15, 2014
• Est. primary completion date: September 15, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Hypercholesterolemia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (1)

Ferrières J, Dallongeville J, Rossignol M, Bénichou J, Caro JJ, Getsios D, Hernandez L, Abenhaim L, Grimaldi-Bensouda L. Model-observational bridging study on the effectiveness of ezetimibe on cardiovascular morbidity and mortality in France: A population — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Cardiovascular (CV) Events	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.	up to 48 months
Secondary	Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Levels at 12 Months	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.	Baseline and Month 12
Secondary	Percentage of Participants With CV Risk Factors	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.	At enrollment (baseline)
Secondary	Percentage of Participants Who Continued Treatment for 12, 24, 36, and 48 Months	Participants' data reviewed and the number of participants who had continued treatment for 12, 24, 36, and 48 months was recorded.	up to 48 months
Secondary	Percentage of Participants With at Least 1 Discontinuation of Study Drug	The percentage of participants who stopped study drug at least once during the study period was recorded and summarized.	up to 48 months
Secondary	Mortality Rate	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.	up to 48 months