Clinical trial

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Effects of Ezetimibe + Simvastatin on Clinical Outcomes in Patients With Aortic Stenosis

Name

0653A-043

Description

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.

Trial arms

Trial start

2001-01-01

Estimated PCD

2008-04-01

Trial end

2008-04-01

Status

Completed

Phase

Early phase I

Treatment

ezetimibe (+) simvastatin

Duration of Treatment: 4 years

Arms:

EZ/Simva 10/40 mg

Other names:

MK0653A

Comparator: Placebo

matching Placebo

Arms:

Placebo

Size

1873

Primary endpoint

Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of MCE (Major Cardiovascular Events)

Entire follow-up (median = 4.35 years)

Eligibility criteria

Inclusion Criteria: * Patients aged 45 to 85 with mild abnormalities of the aortic valve as confirmed by an echocardiogram. Exclusion Criteria: * Patients previously in a trial using the study drug, or currently taking any medications that are not allowed in this study.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 1873, 'type': 'ACTUAL'}}

Updated at

2024-05-16

1 organization

2 products

1 indication

Organization

Organon and Co

Product

Ezetimibe + Simvastatin

Indication

Aortic Stenosis

Product

Comparator