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PULSAR - A Prospective Study to Evaluate the Utility of Low Doses of the Statins Atorvastatin and Rosuvastatin.

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00329173
Enrollment
1000
Registered
2006-05-24
Start date
2003-11-30
Completion date
2004-08-31
Last updated
2009-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolaemia

Brief summary

To compare reduction of LDL-C and safety between 10mg rosuvastatin and 20mg atorvastatin after 6 weeks treatment

Interventions

DRUGRosuvastatin
DRUGAtorvastatin

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* History of statin induced myopathy, or serious hypersensitivity reaction to other HMG-CoA reductase inhibitors (statins), including rosuvastatin * Pregnancy * History of homozygous familial hypercholesterolaemia.

Design outcomes

Primary

MeasureTime frame
Reduction in LDL-c after 6 weeks—

Secondary

MeasureTime frame
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—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026