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

Phase 3

Completed

• Conditions: Hypercholesterolaemia

• Registration Number: NCT00329173
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-11
• Study Completion: 2004-08
• Study First Submitted: 2006-05-22
• Study First Submitted QC: 2006-05-22
• Study First Posted: 2006-05-24
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-13
• Last Update Posted: 2009-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reduction in LDL-c after 6 weeks

Secondary Outcome Measures

Name	Time	Method
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