A Phase 3 interventional study of Rosuvastatin and Placebo in Aortic Stenosis, sponsored by AstraZeneca. Completed at 15 sites in Canada. Open to participants aged 18 Years to 82 Years. Per ClinicalTrials.gov, last updated 2010-12-03.
Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment
The purpose of this study is to assess the effects of rosuvastatin compared to usual care in patients diagnosed with aortic valvular stenosis. Patients must have a diagnosis of mild to moderate aortic stenosis (AS) and no clinical indication for the use of cholesterol lowering agents. A multi-centre, randomized, double-blind, placebo-controlled study, with a two year recruitment period, and a treatment duration of a minimum of 3 years from the time of the last patient randomized to a maximum of 5 years.
985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.
This study's planned enrollment of 378 is above the median of 120 across 525 interventional studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Rosuvastatin 40 mg
Drug: Rosuvastatin
placebo
Drug: Placebo
40 mg, oral, single dose
oral, single dose
The changes in transvalvular aortic velocities and the changes in aortic valve area.
Time frame: Between baseline and close-out measurments.
The incidence and severity of adverse events, the clinically relevant changes in echocardiograms, and laboratory analysis will be compared between the two treatment groups.
Time frame: Baseline and minimum of 3 year follow-up.
The incidence and severity of adverse events, the clinically relevant changes in echocardiograms, and laboratory analysis will be compared between the two treatment groups.
Time frame: Between baseline and close-out measurments.
This study is completed, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.
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AstraZeneca