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

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ClinicalTrials.gov Identifier: NCT00329173
Recruitment Status : Completed
First Posted : May 24, 2006
Last Update Posted : March 16, 2009
Sponsor:
Information provided by:
AstraZeneca

May 22, 2006
May 24, 2006
March 16, 2009
November 2003
Not Provided
Reduction in LDL-c after 6 weeks
Same as current
Complete list of historical versions of study NCT00329173 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
PULSAR - A Prospective Study to Evaluate the Utility of Low Doses of the Statins Atorvastatin and Rosuvastatin.
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
To compare reduction of LDL-C and safety between 10mg rosuvastatin and 20mg atorvastatin after 6 weeks treatment
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hypercholesterolaemia
  • Drug: Rosuvastatin
  • Drug: Atorvastatin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1000
Same as current
August 2004
Not Provided

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00329173
4522IL/0102
PULSAR
D3569C00001
Not Provided
Not Provided
Not Provided
Not Provided
AstraZeneca
Not Provided
Study Director: Crestor Medical Science Director, MD AstraZeneca
AstraZeneca
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP