STELLAR-Rosuvastatin vs. Atorvastatin, Pravastatin, Simvastatin Across Dose Ranges

AstraZeneca5,625 enrolled

Overview

To compare the efficacy of various doses of rosuvastatin with atorvastatin, pravastatin \& simvastatin in reducing levels of low density lipoprotein cholesterol in subjects with hypercholesterolaemia.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

5,625

Conditions

Hypercholesterolemia

Interventions

RosuvastatinDRUG

AtorvastatinDRUG

PravastatinDRUG

SimvastatinDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Discontinuation of all previous lipid lowering therapy. * Fasting LDL-c levels of between 160mg/dl - 250 mg/dl at Visits 2 \& 3 for subjects not on lipid lowering therapy at Visit 1. * Other lipid parameters as specified in the protocol. Exclusion Criteria: * The use of lipid lowering drugs or dietary supplements after Visit 1. * Active arterial disease eg Unstable angina, or recent arterial surgery * Abnormal laboratory parameters as defined in the protocol.

Outcomes

Primary Outcomes

Percentage change in low density lipoprotein cholesterol.

Time frame: 4 & 6 weeks

Secondary Outcomes

Percentage change in other lipid parameters as defined by the protocol

Time frame: 6 weeks

Safety evaluation

Time frame: 6 weeks

Data from ClinicalTrials.gov

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