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An Investigational Drug on Clinical Outcomes in Patients With Aortic Stenosis (Narrowing of the Major Blood Vessel of the Heart)(MK-0653A-043 AM4)(COMPLETED)

NCT00092677 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1873

Last updated 2024-05-16

Study results available
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Summary

The purpose of this study is to evaluate whether treatment with an investigational drug as compared to placebo will reduce the risk of major cardiovascular events in patients with aortic stenosis.

Conditions

  • Aortic Stenosis

Interventions

DRUG

ezetimibe (+) simvastatin

Duration of Treatment: 4 years

DRUG

Comparator: Placebo

matching Placebo

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-01-31
Primary Completion
2008-04-30
Completion
2008-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00092677 on ClinicalTrials.gov