| September 23, 2004 |
| November 6, 2009 |
| March 2001 |
| April 2008 (final data collection date for primary outcome measure) |
| 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 ] |
| Composite clinical endpoint of MCE. |
| Complete list of historical versions of study NCT00092677 on ClinicalTrials.gov Archive Site |
- 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 ]
|
| Composite clinical endpoint of AVE and composite clinical endpoint ICE. |
| |
| An Investigational Drug on Clinical Outcomes in Patients With Aortic Stenosis (Narrowing of the Major Blood Vessel of the Heart) |
| A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Effects of Ezetimibe + Simvastatin on Clinical Outcomes in Patients With Aortic Stenosis |
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. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Aortic Stenosis |
- Drug: ezetimibe (+) simvastatin
- Drug: Comparator: Placebo
|
| Experimental: Ezetimibe 10 mg + Simvastatin 40 mg |
- 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.
- 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.
|
| |
| Completed |
| 1873 |
|
| April 2008 (final data collection date for primary outcome measure) |
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.
|
| Both |
| 45 Years to 85 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
|
| |
| NCT00092677 |
| Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc. |
| 2004_050, MK0653A-043 |
| Merck |
|
| Study Director: |
Medical Monitor |
Merck |
|
|
| Merck |
| November 2009 |
