- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00228514
Dutch Sub Study: Controlled Rosuvastatin Multinational Study in Heart Failure (CORONA). PET Sub Study
November 11, 2010 updated by: AstraZeneca
Sub Study: Controlled Rosuvastatin Multinational Study in Heart Failure (CORONA) PET Sub Study
At one site, patients participating in the Corona main study are asked to participate in the PET-substudy.
Before and 6 months after study medication is started a Positron Emission Tomography (PET-scan) is performed to study the effect of rosuvastatin in Chronic Heart Failure on myocardial perfusion (reserve)
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment
40
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Groningen, Netherlands
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients fulfilling the in and exclusion criteria of the CORONA study and separate informed consent for participation in the sub study.
Exclusion Criteria:
- See above
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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To study the effect of rosuvastatin in Chronic Heart Failure on myocardial perfusion (reserve). Before and 6 months after study medication is started a Positron Emission Tomography (PET-scan) is performed.
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Secondary Outcome Measures
Outcome Measure |
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To study the effect of rosuvastatin in Chronic Heart Failure on mismatch. Before and 6 months after study medication is started a Positron Emission Tomography (PET-scan) is performed.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: AstraZeneca CV Medical Department, AstraZeneca BV
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2004
Study Completion (Actual)
July 1, 2007
Study Registration Dates
First Submitted
September 27, 2005
First Submitted That Met QC Criteria
September 27, 2005
First Posted (Estimate)
September 29, 2005
Study Record Updates
Last Update Posted (Estimate)
November 15, 2010
Last Update Submitted That Met QC Criteria
November 11, 2010
Last Verified
November 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4522IL/0098 Dutch SubStudy
- D3562C00098
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.