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Sponsors and Collaborators: |
AstraZeneca University of Ottawa Heart Institute |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00800800 |
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.
Condition | Intervention | Phase |
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Aortic Stenosis |
Drug: Rosuvastatin Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Efficacy Study |
Official Title: | Effect of Cholesterol Lowering on the Progression of Aortic Stenosis in Patients With Mild to Moderate Aortic Stenosis (ASTRONOMER)Aortic Stenosis Progression Observation Measuring Effects of Rosuvastatin and The Sub-Study Protocol. |
Estimated Enrollment: | 378 |
Study Start Date: | November 2002 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Rosuvastatin 40 mg
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Drug: Rosuvastatin
40 mg, oral, single dose
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2: Placebo Comparator
placebo
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Drug: Placebo
oral, single dose
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Ages Eligible for Study: | 18 Years to 82 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: AstraZeneca Canada Inc | 800-565-5877 ext 6864 | lara.chayab@astrazeneca.com |
Canada | |
Research site | Recruiting |
St. John's, Canada | |
Research site | Recruiting |
Halifax, Canada | |
Canada, Alberta | |
Research site | Recruiting |
Calgary, Alberta, Canada | |
Research site | Recruiting |
Edmonton, Alberta, Canada | |
Canada, British Columbia | |
Research site | Recruiting |
Vancouver, British Columbia, Canada | |
Research site | Recruiting |
Victoria, British Columbia, Canada | |
Research site | Recruiting |
Surrey, British Columbia, Canada | |
Canada, Manitoba | |
Research site | Recruiting |
Edmonton, Manitoba, Canada | |
Canada, Ontario | |
Research site | Recruiting |
Ottawa, Ontario, Canada | |
Research site | Recruiting |
Toronto, Ontario, Canada | |
Research site | Recruiting |
Kitchener, Ontario, Canada | |
Research site | Recruiting |
Montreal, Ontario, Canada | |
Research site | Recruiting |
Brampton, Ontario, Canada | |
Research site | Recruiting |
Cambridge, Ontario, Canada | |
Canada, Quebec | |
Research site | Recruiting |
Montreal, Quebec, Canada |
Responsible Party: | AstraZeneca Canada ( Andrew Vieira ) |
Study ID Numbers: | DC-452-0003 |
Study First Received: | November 25, 2008 |
Last Updated: | December 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00800800 |
Health Authority: | Canada: Canadian Institutes of Health Research; Canada: Ethics Review Committee; Canada: Health Canada |
progression of aortic stenosis |
Pathological Conditions, Anatomical Rosuvastatin Heart Diseases Disease Progression |
Constriction, Pathologic Aortic valve stenosis Aortic Valve Stenosis Heart Valve Diseases |
Antimetabolites Disease Attributes Pathologic Processes Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antilipemic Agents |
Enzyme Inhibitors Cardiovascular Diseases Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Ventricular Outflow Obstruction |