Back to resultsPULSAR - A Prospective Study to Evaluate the Utility of Low Doses of the Statins Atorvastatin and Rosuvastatin.
Primary Purpose
Hypercholesterolaemia
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Rosuvastatin
Atorvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolaemia
Eligibility 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.
Sites / Locations
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00329173
Brief Title
PULSAR - A Prospective Study to Evaluate the Utility of Low Doses of the Statins Atorvastatin and Rosuvastatin.
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
To compare reduction of LDL-C and safety between 10mg rosuvastatin and 20mg atorvastatin after 6 weeks treatment
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolaemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Primary Outcome Measure Information:
Title
Reduction in LDL-c after 6 weeks
Secondary Outcome Measure Information:
Title
Changes in other lipids and lipoproteins
Title
Achievement of NCEP -ATP III target goal LDL-Cholesterol and non HDL-C
Title
Achievement of EAS LDL-c and non HDL-C target goals after 6 weeks treatment.
Title
Comparison of cost effectiveness and also safety
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Crestor Medical Science Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
PULSAR - A Prospective Study to Evaluate the Utility of Low Doses of the Statins Atorvastatin and Rosuvastatin.
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