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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00654173

Collaborator

(none)

4,444

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hypercholesterolemia	Drug: Rosuvastatin Drug: Simvastatin Drug: Atorvastatin	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

4444 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A 12-Week, Randomized, Open-Label, 3 Arm Parallel Group, Multicenter, Phase IIIb Study Comparing the Efficacy and Safety of Rosuvastatin With Atorvastatin and Simvastatin Achieving NCEP ATP III LDL-C Goals in High Risk Subjects With Hypercholesterolaemia in the Managed Care Setting.

Study Start Date :

Jun 1, 2002

Actual Study Completion Date :

Sep 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Rosuvastatin	Drug: Rosuvastatin Other Names: Crestor
Active Comparator: 2 Simvastatin	Drug: Simvastatin Other Names: Zocor
Active Comparator: 3 Atorvastatin	Drug: Atorvastatin Other Names: Lipitor

Arm

Intervention/Treatment

Experimental: 1

Rosuvastatin

Drug: Rosuvastatin

Other Names:

Crestor

Active Comparator: 2

Simvastatin

Drug: Simvastatin

Other Names:

Zocor

Active Comparator: 3

Atorvastatin

Drug: Atorvastatin

Other Names:

Lipitor

Outcome Measures

Primary Outcome Measures

Percentage of subjects who achieve low density lipoprotein cholesterol goals while receiving treatment with rosuvastatin, compared to subjects receiving treatment with simvastatin or atorvastatin. [6 weeks]

Secondary Outcome Measures

Percentage changes in other blood lipid levels while receiving treatment with rosuvastatin, compared to subjects receiving treatment with simvastatin or atorvastatin [6 & 12 weeks]
Safety: adverse events & abnormal laboratory markers [6 & 12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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