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

This study has been completed.

First Received: May 22, 2006 Last Updated: March 13, 2009 History of Changes

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00329173

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol

Drug Information available for: Atorvastatin Atorvastatin calcium Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00329173

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Crestor Medical Science Director, MD

AstraZeneca

More Information

No publications provided

Study ID Numbers:	4522IL/0102, PULSAR, D3569C00001
Study First Received:	May 22, 2006
Last Updated:	March 13, 2009
ClinicalTrials.gov Identifier:	NCT00329173 History of Changes
Health Authority:	Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Additional relevant MeSH terms:

Antimetabolites
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Pharmacologic Actions
Rosuvastatin
Therapeutic Uses
Hypercholesterolemia
Dyslipidemias
Atorvastatin
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010