RosuvastatinPhase 3NCT00228514
Dutch Sub Study: Controlled Rosuvastatin Multinational Study in Heart Failure (CORONA). PET Sub Study
A Phase 3 study testing Rosuvastatin and Positron emission tomography in people with Rosuvastatin and Heart Failure, run by AstraZeneca at 1 site in Netherlands.
Trial summary
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) Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Rosuvastatin, Heart Failure, Positron Emission Tomography (PET)
- What is being tested?
- Rosuvastatin and Positron emission tomography
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2004to Jul 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients fulfilling the in and exclusion criteria of the CORONA study and separate informed consent for participation in the sub study.
Who cannot join
- See above
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
- Being tested
- Rosuvastatin, Positron emission tomography
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Also called Crestor
Positron emission tomographyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Secondary outcomes (1)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2005 (estimated)
- Study startFeb 2004
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RosuvastatinStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca CV Medical Department, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00228514
- Sponsor's protocol ID
- 4522IL/0098 Dutch SubStudy
- Other IDs
- D3562C00098
- Status last verified
- Nov 2010
- First submitted
- 27 Sep 2005
- Last updated
- 15 Nov 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sub Study: Controlled Rosuvastatin Multinational Study in Heart Failure (CORONA) PET Sub Study
- ClinicalTrials.gov ID
- NCT00228514
- Acronym / sponsor ID
- 4522IL/0098 Dutch SubStudy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Study completion
- Jul 2007 (actual)
- First posted
- 29 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients fulfilling the in and exclusion criteria of the CORONA study and separate informed consent for participation in the sub study.
Key exclusion criteria (1 listed)
- See above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RosuvastatinAlso: Crestor | Drug | – |
| Positron emission tomography | Procedure or surgery | – |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AstraZeneca CV Medical Department study director
AstraZeneca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rosuvastatin and Positron emission tomography in people with Rosuvastatin and Heart Failure, run by AstraZeneca at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2010.