Comparing the Efficacy and Safety of Rosuvastatin With Atorvastatin and Simvastatin (SOLAR)

AstraZeneca4,444 enrolled

Overview

The purpose of this study is to compare the efficacy and safety of rosuvastatin with simvastatin and atorvastatin in reducing levels of low density lipoprotein cholesterol in subjects with hypercholesterolaemia

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

4,444

Conditions

Hypercholesterolemia

Interventions

RosuvastatinDRUG

SimvastatinDRUG

AtorvastatinDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Member of managed care plan for hypercholesterolemia * Fasting blood lipid levels as defined by the protocol * Diagnosis of coronary heart disease, diabetes, or atherosclerotic disease, or presence of multiple risk factors giving high risk of coronary heart disease Exclusion Criteria: * The use of lipid lowering drugs or dietary supplements after Visit 1. * Active arterial disease eg Unstable angina, or recent arterial surgery * Blood lipid levels above the limits defined in the protocol. * Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse

Outcomes

Primary Outcomes

Percentage of subjects who achieve low density lipoprotein cholesterol goals while receiving treatment with rosuvastatin, compared to subjects receiving treatment with simvastatin or atorvastatin.

Time frame: 6 weeks

Secondary Outcomes

Percentage changes in other blood lipid levels while receiving treatment with rosuvastatin, compared to subjects receiving treatment with simvastatin or atorvastatin

Time frame: 6 & 12 weeks

Safety: adverse events & abnormal laboratory markers

Time frame: 6 & 12 weeks

Data from ClinicalTrials.gov

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