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

May 22, 2006
March 13, 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00329173
4522IL/0102, PULSAR, D3569C00001
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