Brief Title
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)
Official Title
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of MCE (Major Cardiovascular Events)
Secondary Outcome
Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of AVE (Aortic Valve Events)
Condition
Aortic Stenosis
Intervention
ezetimibe (+) simvastatin
Study Arms / Comparison Groups
EZ/Simva 10/40 mg
Description: Ezetimibe 10 mg + Simvastatin 40 mg
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
Drug
Estimated Enrollment
1873
Start Date
January 2001
Completion Date
April 2008
Primary Completion Date
April 2008
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.
Gender
All
Ages
45 Years - 85 Years
Accepts Healthy Volunteers
No
Contacts
Medical Monitor, ,
Administrative Informations
NCT ID
NCT00092677
Organization ID
0653A-043
Secondary IDs
2004_050
Responsible Party
Sponsor
Study Sponsor
Merck Sharp & Dohme Corp.
Study Sponsor
Medical Monitor, Study Director, Merck Sharp & Dohme Corp.
Verification Date
March 2017