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

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00092677

Purpose

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.

Condition	Intervention	Phase
Aortic Stenosis	Drug: ezetimibe (+) simvastatin Drug: Comparator: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

Drug Information available for: Simvastatin Ezetimibe

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	1873
Study Start Date:	March 2001
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
EZ/Simva 10/40 mg: Experimental Ezetimibe 10 mg + Simvastatin 40 mg	Drug: ezetimibe (+) simvastatin Duration of Treatment: 4 years
Placebo: Placebo Comparator	Drug: Comparator: Placebo matching Placebo

Eligibility

Ages Eligible for Study:	45 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00092677

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Rossebø AB, Pedersen TR, Boman K, Brudi P, Chambers JB, Egstrup K, Gerdts E, Gohlke-Bärwolf C, Holme I, Kesäniemi YA, Malbecq W, Nienaber CA, Ray S, Skjaerpe T, Wachtell K, Willenheimer R; SEAS Investigators. Intensive lipid lowering with simvastatin and ezetimibe in aortic stenosis. N Engl J Med. 2008 Sep 25;359(13):1343-56. Epub 2008 Sep 2.

Steine K, Rossebø AB, Stugaard M, Pedersen TR. Left ventricular systolic and diastolic function in asymptomatic patients with moderate aortic stenosis. Am J Cardiol. 2008 Oct 1;102(7):897-901. Epub 2008 Aug 26.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Cramariuc D, Cioffi G, Rieck AE, Devereux RB, Staal EM, Ray S, Wachtell K, Gerdts E. Low-flow aortic stenosis in asymptomatic patients: valvular-arterial impedance and systolic function from the SEAS Substudy. JACC Cardiovasc Imaging. 2009 Apr;2(4):390-9.

Responsible Party:	Merck Sharp & Dohme Corp ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2004_050, MK0653A-043
Study First Received:	September 23, 2004
Results First Received:	March 31, 2009
Last Updated:	January 21, 2010
ClinicalTrials.gov Identifier:	NCT00092677 History of Changes
Health Authority:	Norway: Norwegian Medicines Agency

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Antimetabolites
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Simvastatin
Antilipemic Agents
Enzyme Inhibitors
Constriction, Pathologic
Ezetimibe

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Heart Valve Diseases
Therapeutic Uses
Cardiovascular Diseases
Aortic Valve Stenosis
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on February 04, 2010