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

NCT ID: NCT00654173

Last Updated: 2009-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

4444 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2004-09-30

Brief Summary

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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

Detailed Description

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Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Rosuvastatin

Group Type EXPERIMENTAL

Rosuvastatin

Intervention Type DRUG

2

Simvastatin

Group Type ACTIVE_COMPARATOR

Simvastatin

Intervention Type DRUG

3

Atorvastatin

Group Type ACTIVE_COMPARATOR

Atorvastatin

Intervention Type DRUG

Interventions

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Rosuvastatin

Intervention Type DRUG

Simvastatin

Intervention Type DRUG

Atorvastatin

Intervention Type DRUG

Other Intervention Names

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Crestor Zocor Lipitor

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Principal Investigators

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Alex Gold, MD

Role: PRINCIPAL_INVESTIGATOR

AstraZeneca

Russell Esterline

Role: STUDY_DIRECTOR

AstraZeneca

Other Identifiers

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D3560L00023

Identifier Type: -

Identifier Source: secondary_id

4522US/0003

Identifier Type: -

Identifier Source: org_study_id

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