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STELLAR-Rosuvastatin vs. Atorvastatin, Pravastatin, Simvastatin Across Dose Ranges

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.

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00654537
Acronym
STELLAR
Enrollment
5625
Registered
2008-04-08
Start date
2001-04-30
Completion date
2004-10-31
Last updated
2009-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia

Keywords

Cholesterol, hypercholesterolemia, low density lipoproteins

Brief 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.

Interventions

DRUGRosuvastatin
DRUGAtorvastatin
DRUGPravastatin
DRUGSimvastatin

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Percentage change in low density lipoprotein cholesterol.4 & 6 weeks

Secondary

MeasureTime frame
Percentage change in other lipid parameters as defined by the protocol6 weeks
Safety evaluation6 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026