Comparing the Efficacy and Safety of Rosuvastatin With Atorvastatin and Simvastatin (SOLAR)
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypercholesterolemia
Intervention: Rosuvastatin (Drug); Simvastatin (Drug); Atorvastatin (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s): Alex Gold, MD, Principal Investigator, Affiliation: AstraZeneca Russell Esterline, Study Director, Affiliation: AstraZeneca
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
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Percentage of subjects who achieve low density lipoprotein cholesterol goals while receiving treatment with rosuvastatin, compared to subjects receiving treatment with simvastatin or atorvastatin.
Secondary outcome: Percentage changes in other blood lipid levels while receiving treatment with rosuvastatin, compared to subjects receiving treatment with simvastatin or atorvastatinSafety: adverse events & abnormal laboratory markers
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: June 2002
Last updated: March 13, 2009
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