CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,873 enrolled
Drug / intervention
ezetimibe (+) simvastatin +1 moredrug
Likely dose
Ezetimibe + simvastatin (specific dose not stated)AI-extracted
Key inclusion· 2
  • ✓Age 45 to 85 years
  • ✓Mild abnormalities of the aortic valve confirmed by echocardiogram
Key exclusion· 2
  • ✕Prior participation in trial using the study drug
  • ✕Currently taking medications not allowed in this study

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00092677
NCT00092677Phase 3Completed
CompareCT.gov

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

Organon and Co·interventional·Posted Sep 28, 2004·Updated May 16, 2024

In Brief

A Phase 3 clinical trial evaluating ezetimibe (+) simvastatin and Comparator: Placebo for Aortic Stenosis. Completed, enrolled 1,873 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAortic Stenosis
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 28, 2004
Enrollment StartJan 1, 2001
Primary CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 21.8 years ago

Interventions

ezetimibe (+) simvastatindrug

Duration of Treatment: 4 years

Comparator: Placebodrug

matching Placebo