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

NCT ID: NCT00329173

Last Updated: 2009-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-11-30
• Study Completion Date: 2004-08-31

Brief Summary

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

Conditions

Hypercholesterolaemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Rosuvastatin

Intervention Type: DRUG

Atorvastatin

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Principal Investigators

Crestor Medical Science Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Other Identifiers

PULSAR

Identifier Type: -

Identifier Source: secondary_id

D3569C00001

Identifier Type: -

Identifier Source: secondary_id

4522IL/0102

Identifier Type: -

Identifier Source: org_study_id