Phase 3 N=1,873 Randomized Double-blind Treatment

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)

Aortic Stenosis

Bottom Line

View on ClinicalTrials.gov: NCT00092677 ↗

Enrolled (actual)

1,873

Serious AEs

—

Results posted

May 2009

Primary outcome: Primary: Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of MCE (Major Cardiovascular Events) — 333; 355 Participants — p=0.591

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: ezetimibe (+) simvastatin (Drug); Comparator: Placebo (Drug)
Age: Adult, Older Adult · 45+ yrs
Sex: All
Sponsor: Organon and Co
Primary completion: Apr 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of MCE (Major Cardiovascular Events)	333; 355	0.591
SECONDARY Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of AVE (Aortic Valve Events)	308; 326	0.732
SECONDARY Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of ICE (Ischemic Cardiovascular Events)	148; 187	0.024 sig
SECONDARY Change From Baseline in Peak Transaortic Jet Velocity	0.613; 0.618	0.829

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00092677). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.