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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 protocol

Safety 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

Page last updated: August 23, 2015

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