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

Phase 3CompletedNCT00329173

AstraZeneca1,000 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,000

Conditions

Hypercholesterolaemia

Interventions

RosuvastatinDRUG

AtorvastatinDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Reduction in LDL-c after 6 weeks

Secondary Outcomes

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

Data from ClinicalTrials.gov

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