HypercholesterolaemiaPhase 3NCT00329173
PULSAR - A Prospective Study to Evaluate the Utility of Low Doses of the Statins Atorvastatin and Rosuvastatin.
A Phase 3 study testing Rosuvastatin and Atorvastatin in people with Hypercholesterolaemia, run by AstraZeneca.
Trial summary
To compare reduction of LDL-C and safety between 10mg rosuvastatin and 20mg atorvastatin after 6 weeks treatment Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercholesterolaemia
- What is being tested?
- Rosuvastatin and Atorvastatin
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Nov 2003to Aug 2004
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female 18 or over.
- A history of CHD or clinical evidence of atherosclerosis (diabetic or non-diabetic) or a CHD risk equivalent (10-year risk score > 20% for CHD as described in NCEP ATP III guidelines1.
Who cannot join
- History of statin induced myopathy, or serious hypersensitivity reaction to other HMG-CoA reductase inhibitors (statins), including rosuvastatin
- Pregnancy
- History of homozygous familial hypercholesterolaemia.
About this study
Official title: A 6-Week Open-Label, Randomised, Multicentre, Phase IIIb, Parallel-Group Study to Compare the Efficacy and Safety of Rosuvastatin (10 mg) With Atorvastatin (20 mg) in Subjects With Hypercholesterolaemia and Either a History of CHD or Clinical Evidence of CHD
To compare reduction of LDL-C and safety between 10mg rosuvastatin and 20mg atorvastatin after 6 weeks treatment
- Conditions
- Hypercholesterolaemia
- Being tested
- Rosuvastatin, Atorvastatin
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
AtorvastatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in LDL-c after 6 weeks
Secondary outcomes (4)
Changes in other lipids and lipoproteins
Achievement of NCEP -ATP III target goal LDL-Cholesterol and non HDL-C
Achievement of EAS LDL-c and non HDL-C target goals after 6 weeks treatment.
Comparison of cost effectiveness and also safety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2006 (estimated)
- Study startNov 2003
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolaemiaStudies 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
- None (open label)
- Enrolment
- 1,000 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Crestor Medical Science Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00329173
- Sponsor's protocol ID
- 4522IL/0102
- Other IDs
- PULSAR, D3569C00001
- Status last verified
- Mar 2009
- First submitted
- 22 May 2006
- Last updated
- 16 Mar 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-Week Open-Label, Randomised, Multicentre, Phase IIIb, Parallel-Group Study to Compare the Efficacy and Safety of Rosuvastatin (10 mg) With Atorvastatin (20 mg) in Subjects With Hypercholesterolaemia and Either a History of CHD or Clinical Evidence of CHD
- ClinicalTrials.gov ID
- NCT00329173
- Acronym / sponsor ID
- 4522IL/0102
- Conditions
- Hypercholesterolaemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2003
- Study completion
- Aug 2004 (actual)
- First posted
- 24 May 2006 (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 compare reduction of LDL-C and safety between 10mg rosuvastatin and 20mg atorvastatin after 6 weeks treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female 18 or over.
- A history of CHD or clinical evidence of atherosclerosis (diabetic or non-diabetic) or a CHD risk equivalent (10-year risk score > 20% for CHD as described in NCEP ATP III guidelines1.
Key exclusion criteria (3 listed)
- History of statin induced myopathy, or serious hypersensitivity reaction to other HMG-CoA reductase inhibitors (statins), including rosuvastatin
- Pregnancy
- History of homozygous familial hypercholesterolaemia.
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 | – |
| Atorvastatin | Drug | – |
Primary outcome
Reduction in LDL-c after 6 weeks
4 secondary outcomes
Changes in other lipids and lipoproteins
Achievement of NCEP -ATP III target goal LDL-Cholesterol and non HDL-C
Achievement of EAS LDL-c and non HDL-C target goals after 6 weeks treatment.
Comparison of cost effectiveness and also safety
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 16 Mar 2009.
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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.
Crestor Medical Science Director, MD study director
AstraZeneca
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rosuvastatin and Atorvastatin in people with Hypercholesterolaemia, run by AstraZeneca.
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 2 inclusion and 3 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 16 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
Reduction in LDL-c after 6 weeks. 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 16 Mar 2009.