HypercholesterolemiaPhase 3NCT00240279
The Effect of Rosuvastatin on Aortic Stiffness in Hemodialysis Patients in the AURORA Study
A Phase 3 study testing Rosuvastatin and aortic pulse wave velocity measurements in people with Hypercholesterolemia, run by AstraZeneca at 1 site in Netherlands.
Trial summary
To investigate the effect of rosuvastatin compared to placebo on the aortic stiffness in hemodialysis patients as measured by pulse wave velocity (at 3, 6 and 12 months) Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Rosuvastatin and aortic pulse wave velocity measurements
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2003to Oct 2008
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent, between 50 and 80 years of age, end stage renal failure patients receiving hemodialysis
Who cannot join
- Received statins within past 6 months, a clear indication for use of lipid altering drug, contra indication for lipid altering drug, history of statin induced myopathy items in very
Trial locations and contacts
1 site in 1 country.
About this study
To investigate the effect of rosuvastatin compared to placebo on the aortic stiffness in hemodialysis patients as measured by pulse wave velocity (at 3, 6 and 12 months)
- Conditions
- Hypercholesterolemia
- Being tested
- Rosuvastatin, aortic pulse wave velocity measurements
- Keywords
- high blood cholesterol levels
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
aortic pulse wave velocity measurementsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the effect of rosuvastatin compared to placebo on the aortic stiffness in hemodialysis patients as measured by pulse wave velocity (at 3, 6 and 12 months)
Secondary outcomes (1)
To investigate the effect of rosuvastatin compared to placebo on the aortic pressure wave in hemodialysis patients (at 3 months/ 6 months and 12 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2005 (estimated)
- Study startJan 2003
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies 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
- 10 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Crestor Medical Sciences Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00240279
- Sponsor's protocol ID
- 4522IL/0096 Dutch SubStudy
- Other IDs
- D3562C00096
- Status last verified
- Nov 2010
- First submitted
- 16 Oct 2005
- Last updated
- 19 Nov 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Rosuvastatin on Aortic Stiffness in Hemodialysis Patients in the AURORA Study
- ClinicalTrials.gov ID
- NCT00240279
- Acronym / sponsor ID
- 4522IL/0096 Dutch SubStudy
- Conditions
- Hypercholesterolemia
- Keywords
- high blood cholesterol levels
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 18 Oct 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.
To investigate the effect of rosuvastatin compared to placebo on the aortic stiffness in hemodialysis patients as measured by pulse wave velocity (at 3, 6 and 12 months)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Signed informed consent, between 50 and 80 years of age, end stage renal failure patients receiving hemodialysis
Key exclusion criteria (1 listed)
- Received statins within past 6 months, a clear indication for use of lipid altering drug, contra indication for lipid altering drug, history of statin induced myopathy items in very
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 |
|---|---|---|
| Rosuvastatin | Drug | – |
| aortic pulse wave velocity measurements | Procedure or surgery | – |
Primary outcome
To investigate the effect of rosuvastatin compared to placebo on the aortic stiffness in hemodialysis patients as measured by pulse wave velocity (at 3, 6 and 12 months)
1 secondary outcome
To investigate the effect of rosuvastatin compared to placebo on the aortic pressure wave in hemodialysis patients (at 3 months/ 6 months and 12 months).
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 19 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 Crestor Medical Sciences Director, MD 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 aortic pulse wave velocity measurements in people with Hypercholesterolemia, 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 19 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 investigate the effect of rosuvastatin compared to placebo on the aortic stiffness in hemodialysis patients as measured by pulse wave velocity (at 3, 6 and 12 months). 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 19 Nov 2010.