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OpenTrials
Completed

NCT Number: NCT00329173

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

To compare reduction of LDL-C and safety between 10mg rosuvastatin and 20mg atorvastatin after 6 weeks treatment

Completed

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Key information

Conditions

Hypercholesterolaemia Dyslipidemias Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rosuvastatin

Drug

atorvastatin

Drug

Primary outcomes

  1. Reduction in LDL-c after 6 weeks

Secondary outcomes

  1. Changes in other lipids and lipoproteins

  2. Achievement of NCEP -ATP III target goal LDL-Cholesterol and non HDL-C

  3. Achievement of EAS LDL-c and non HDL-C target goals after 6 weeks treatment.

  4. Comparison of cost effectiveness and also safety

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2003
Study completion
2004
First posted
May 24, 2006
Registry last updated
Mar 16, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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