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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00654537
First received: April 3, 2008
Last updated: March 13, 2009
Last verified: March 2009
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

MedlinePlus related topics: Cholesterol
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00654537

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

No publications provided

Responsible Party: Elisabeth Björk, AstraZeneca
ClinicalTrials.gov Identifier: NCT00654537     History of Changes
Other Study ID Numbers: 4522IL/0065, D3560C00065
Study First Received: April 3, 2008
Last Updated: March 13, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Cholesterol
hypercholesterolemia
low density lipoproteins

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

ClinicalTrials.gov processed this record on May 23, 2013