An Investigational Drug on Clinical Outcomes in Patients With Aortic Stenosis (Narrowing of the Major Blood Vessel of the Heart) - Tabular View

Tracking Information

First Received Date ^ICMJE

September 23, 2004

Last Updated Date

January 21, 2010

Start Date ^ICMJE

March 2001

Primary Completion Date

April 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of MCE (Major Cardiovascular Events) [ Time Frame: Entire follow-up (median = 4.35 years) ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Composite clinical endpoint of MCE.

Change History

Complete list of historical versions of study NCT00092677 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of AVE (Aortic Valve Events) [ Time Frame: Entire follow-up (median = 4.35 years) ] [ Designated as safety issue: No ]
Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of ICE (Ischemic Cardiovascular Events) [ Time Frame: Entire follow-up (median = 4.35 years) ] [ Designated as safety issue: No ]
Change From Baseline in Peak Transaortic Jet Velocity [ Time Frame: Baseline to End of follow-up (median = 4.35 years) or pre-aortic valve replacement ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Composite clinical endpoint of AVE and composite clinical endpoint ICE.

Descriptive Information

Brief Title ^ICMJE

An Investigational Drug on Clinical Outcomes in Patients With Aortic Stenosis (Narrowing of the Major Blood Vessel of the Heart)

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Randomized
Control:  Placebo Control
Endpoint Classification:  Safety/Efficacy Study
Intervention Model:  Parallel Assignment
Masking:  Double Blind (Subject, Investigator)
Primary Purpose:  Treatment

Condition ^ICMJE

Aortic Stenosis

Intervention ^ICMJE

Drug: ezetimibe (+) simvastatin
Duration of Treatment: 4 years

Other Name: MK0653A
Drug: Comparator: Placebo
matching Placebo

Study Arms / Comparison Groups

EZ/Simva 10/40 mg: Experimental
Ezetimibe 10 mg + Simvastatin 40 mg

Intervention: Drug: ezetimibe (+) simvastatin
Placebo: Placebo Comparator
Intervention: Drug: Comparator: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1873

Completion Date

Primary Completion Date

April 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

45 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00092677

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp

Study ID Numbers ^ICMJE

2004_050, MK0653A-043

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

January 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP