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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014