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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 atorvastatin

Safety: 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

Page last updated: August 23, 2015

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