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

Condition(s) targeted: Hypercholesterolaemia

Intervention: Rosuvastatin (Drug); Atorvastatin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Crestor Medical Science Director, MD, Study Director, Affiliation: AstraZeneca

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

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

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Reduction in LDL-c after 6 weeks

Secondary outcome:

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Starting date: November 2003
Last updated: May 22, 2006