STELLAR-Rosuvastatin vs. Atorvastatin, Pravastatin, Simvastatin Across Dose Ranges
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); Atorvastatin (Drug); Pravastatin (Drug); Simvastatin (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s): Eleanor Miller, MD, Study Director, Affiliation: AstraZeneca Russell Esterline, Study Chair, Affiliation: AstraZeneca
Summary
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.
Clinical Details
Official title: A 6 Week Open Label, Dose Comparison Study to Evaluate the Safety and Efficacy of Rosuvastatin Versus Atorvastatin, Pravastatin, and Simvastatin in Subjects With Hypercholesterolemia.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Percentage change in low density lipoprotein cholesterol.
Secondary outcome: Percentage change in other lipid parameters as defined by the protocolSafety evaluation
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Additional Information
Starting date: April 2001
Last updated: March 13, 2009
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