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)

Organon

Status and phase: Completed; Phase 3

Conditions: Aortic Stenosis

Treatments: Drug: Comparator: Placebo; Drug: ezetimibe (+) simvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00092677

0653A-043

2004_050 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 1,873 patients

Sex: All

Ages: 45 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,873 participants in 2 patient groups, including a placebo group

EZ/Simva 10/40 mg

Experimental group

Description:

Ezetimibe 10 mg + Simvastatin 40 mg

Treatment:

Drug: ezetimibe (+) simvastatin

Placebo

Placebo Comparator group

Treatment:

Drug: Comparator: Placebo