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PULSAR - A Prospective Study to Evaluate the Utility of Low Doses of the Statins Atorvastatin and Rosuvastatin.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00329173
First Posted: May 24, 2006
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 reduction of LDL-C and safety between 10mg rosuvastatin and 20mg atorvastatin after 6 weeks treatment

Condition Intervention Phase
Hypercholesterolaemia Drug: Rosuvastatin Drug: Atorvastatin 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, Randomised, Multicentre, Phase IIIb, Parallel-Group Study to Compare the Efficacy and Safety of Rosuvastatin (10 mg) With Atorvastatin (20 mg) in Subjects With Hypercholesterolaemia and Either a History of CHD or Clinical Evidence of CHD

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Reduction in LDL-c after 6 weeks

Secondary Outcome Measures:
  • Changes in other lipids and lipoproteins
  • Achievement of NCEP -ATP III target goal LDL-Cholesterol and non HDL-C
  • Achievement of EAS LDL-c and non HDL-C target goals after 6 weeks treatment.
  • Comparison of cost effectiveness and also safety

Estimated Enrollment: 1000
Study Start Date: November 2003
Study Completion Date: August 2004
  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:

  • Male or female 18 or over.
  • A history of CHD or clinical evidence of atherosclerosis (diabetic or non-diabetic) or a CHD risk equivalent (10-year risk score > 20% for CHD as described in NCEP ATP III guidelines1.

Exclusion Criteria:

  • History of statin induced myopathy, or serious hypersensitivity reaction to other HMG-CoA reductase inhibitors (statins), including rosuvastatin
  • Pregnancy
  • History of homozygous familial hypercholesterolaemia.
  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): NCT00329173


Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Crestor Medical Science Director, MD AstraZeneca
  More Information

ClinicalTrials.gov Identifier: NCT00329173     History of Changes
Other Study ID Numbers: 4522IL/0102
PULSAR
D3569C00001
First Submitted: May 22, 2006
First Posted: May 24, 2006
Last Update Posted: March 16, 2009
Last Verified: March 2009

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


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