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

NCT01414192 | Completed Results

• 1 other identifier: 0653A-204
• Study Type: observational
• Target: 3,215
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Dyslipidemia; Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Levels at 12 Months

  Baseline and Month 12

• Percentage of Participants With CV Risk Factors

  At enrollment (baseline)

• Percentage of Participants Who Continued Treatment for 12, 24, 36, and 48 Months

  up to 48 months

• Percentage of Participants With at Least 1 Discontinuation of Study Drug

  up to 48 months

• Mortality Rate

  up to 48 months

Study Arms (4)

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.

Ezetimibe/simvastatin

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The resident population of Continental France being treated for hypercholesterolemia in a general practice setting.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• Ferrieres J, Dallongeville J, Rossignol M, Benichou 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-based study. J Clin Lipidol. 2016 Nov-Dec;10(6):1379-1388. doi: 10.1016/j.jacl.2016.08.015. Epub 2016 Sep 7.

  PMID: 27919355 RESULT

MeSH Terms

Conditions

Dyslipidemias; Hypercholesterolemia

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperlipidemias

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2011
• First Posted: August 11, 2011
• Study Start: November 15, 2008
• Primary Completion: September 15, 2014
• Study Completion: September 15, 2014
• Last Updated: September 5, 2024
• Results First Posted: January 8, 2016

Record last verified: 2022-02