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OpenTrials
Completed

NCT Number: NCT00654537

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

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.

Completed

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rosuvastatin

Drug

Other names: Crestor

atorvastatin

Drug

Other names: Lipitor

Pravastatin

Drug

Other names: Lipostat

simvastatin

Drug

Other names: Zocor

Primary outcomes

  1. Percentage change in low density lipoprotein cholesterol.

    Time frame: 4 & 6 weeks

Secondary outcomes

  1. Percentage change in other lipid parameters as defined by the protocol

    Time frame: 6 weeks

  2. Safety evaluation

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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.

Acronym: STELLAR

Important dates

Study start
2001
Study completion
2004
First posted
Apr 8, 2008
Registry last updated
Mar 16, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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