A Study to Design a Model Cohort for Analysis of Dyslipidemia (MK-0653A-204) (MOBS)
|ClinicalTrials.gov Identifier: NCT01414192|
Recruitment Status : Completed
First Posted : August 11, 2011
Results First Posted : January 8, 2016
Last Update Posted : July 2, 2017
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||3215 participants|
|Official Title:||Model-Observation Bridging Study (MOBS) for Ezetrol® and Inegy®|
|Actual Study Start Date :||November 15, 2008|
|Actual Primary Completion Date :||September 15, 2014|
|Actual Study Completion Date :||September 15, 2014|
Ezetimibe monotherapy without prior treatment
Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
Ezetimibe monotherpay with prior treatment
Enrolled participants with prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
Ezetimibe plus statin
Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin.
Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).
- Rate of Cardiovascular (CV) Events [ Time Frame: up to 48 months ]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.
- Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Levels at 12 Months [ Time Frame: Baseline and Month 12 ]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.
- Percentage of Participants With CV Risk Factors [ Time Frame: At enrollment (baseline) ]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.
- Percentage of Participants Who Continued Treatment for 12, 24, 36, and 48 Months [ Time Frame: up to 48 months ]Participants' data reviewed and the number of participants who had continued treatment for 12, 24, 36, and 48 months was recorded.
- Percentage of Participants With at Least 1 Discontinuation of Study Drug [ Time Frame: up to 48 months ]The percentage of participants who stopped study drug at least once during the study period was recorded and summarized.
- Mortality Rate [ Time Frame: up to 48 months ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01414192
|Study Director:||Medical Director||Merck Sharp & Dohme Corp.|