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

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ClinicalTrials.gov Identifier: NCT00654537
Recruitment Status : Completed
First Posted : April 8, 2008
Last Update Posted : March 16, 2009
Sponsor:
Information provided by:
AstraZeneca

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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: Rosuvastatin Drug: Atorvastatin Drug: Pravastatin Drug: Simvastatin Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5625 participants
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.
Study Start Date : April 2001
Actual Study Completion Date : October 2004


Arm Intervention/treatment
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




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

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

Responsible Party: Elisabeth Björk, AstraZeneca
ClinicalTrials.gov Identifier: NCT00654537     History of Changes
Other Study ID Numbers: 4522IL/0065
D3560C00065
First Posted: April 8, 2008    Key Record Dates
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