Who is sponsoring NCT00092677?

NCT00092677 is sponsored by Organon and Co.

What condition does NCT00092677 study?

NCT00092677 studies Aortic Stenosis.

What drugs are being tested in NCT00092677?

Interventions: ezetimibe (+) simvastatin, Comparator: Placebo.

What is the status of NCT00092677?

NCT00092677 is currently COMPLETED.

Last reviewed 2024-05-08 · How we verify

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

NCT00092677 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Organon and Co
Phase	Phase 3
Status	COMPLETED
Enrolment	1873
Start date	2001-01
Completion	2008-04

Conditions

Aortic Stenosis

Interventions

ezetimibe (+) simvastatin
Comparator: Placebo

Primary outcomes

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)
Composite endpoint of MCE consists of cardiovascular death, AVR (aortic valve replacement) surgery, CHF(congestive heart failure) as a result of progression of aortic stenosis, nonfatal MI (myocardial infarction), CABG (coronary artery bypass) surgery, PCI (percutaneous coronary intervention), hospitalized unstable angina, and nonhemorrhagic stroke