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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00654537
First Posted: April 8, 2008
Last Update Posted: March 16, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  Purpose
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.

Condition Intervention Phase
Hypercholesterolemia Drug: Rosuvastatin Drug: Atorvastatin Drug: Pravastatin Drug: Simvastatin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Percentage change in low density lipoprotein cholesterol. [ Time Frame: 4 & 6 weeks ]

Secondary Outcome Measures:
  • Percentage change in other lipid parameters as defined by the protocol [ Time Frame: 6 weeks ]
  • Safety evaluation [ Time Frame: 6 weeks ]

Estimated Enrollment: 5625
Study Start Date: April 2001
Study Completion Date: October 2004
Arms Assigned Interventions
Experimental: 1
Rosuvastatin
Drug: Rosuvastatin
Other Name: Crestor
Active Comparator: 2
Atorvastatin
Drug: Atorvastatin
Other Name: Lipitor
Active Comparator: 3
Pravastatin
Drug: Pravastatin
Other Name: Lipostat
Active Comparator: 4
Simvastatin
Drug: Simvastatin
Other Name: Zocor

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00654537


Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Eleanor Miller, MD AstraZeneca
Study Chair: Russell Esterline AstraZeneca
  More Information

Responsible Party: Elisabeth Björk, AstraZeneca
ClinicalTrials.gov Identifier: NCT00654537     History of Changes
Other Study ID Numbers: 4522IL/0065
D3560C00065
First Submitted: April 3, 2008
First Posted: April 8, 2008
Last Update Posted: March 16, 2009
Last Verified: March 2009

Keywords provided by AstraZeneca:
Cholesterol
hypercholesterolemia
low density lipoproteins

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin Calcium
Rosuvastatin Calcium
Simvastatin
Pravastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors