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

NCT ID: NCT01414192

Last Updated: 2024-09-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3215 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-11-15

Study Completion Date

2014-09-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Dyslipidemia Hypercholesterolemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ezetimibe monotherapy without prior treatment

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

No interventions assigned to this group

Ezetimibe monotherpay with prior treatment

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

No interventions assigned to this group

Ezetimibe plus statin

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

No interventions assigned to this group

Ezetimibe/simvastatin

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Organon and Co

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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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.

Reference Type RESULT
PMID: 27919355 (View on PubMed)

Other Identifiers

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0653A-204

Identifier Type: -

Identifier Source: org_study_id

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