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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Hypercholesterolaemia

Treatments: Drug: Atorvastatin; Drug: Rosuvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00329173

4522IL/0102

PULSAR

D3569C00001

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)