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

Hypercholesterolaemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00329173
• Other study ID #: 4522IL/0102
• Secondary ID: PULSARD3569C0000
• Status: Completed
• Phase: Phase 3
• First received: May 22, 2006
• Last updated: March 13, 2009
• Start date: November 2003
• Est. completion date: August 2004

Study information

• Verified date: March 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolaemia
• Hypercholesterolemia

Intervention

Drug:
• Rosuvastatin

• Atorvastatin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in LDL-c after 6 weeks
Secondary	Changes in other lipids and lipoproteins
Secondary	Achievement of NCEP -ATP III target goal LDL-Cholesterol and non HDL-C
Secondary	Achievement of EAS LDL-c and non HDL-C target goals after 6 weeks treatment.
Secondary	Comparison of cost effectiveness and also safety