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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00329173
First received: May 22, 2006
Last updated: March 13, 2009
Last verified: March 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

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
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: NCT00329173

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

No publications provided

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

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

ClinicalTrials.gov processed this record on July 23, 2014