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Evaluation of Crestor® (Rosuvastatin) in Daily Practice

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: February 4, 2009
Last updated: February 5, 2009
Last verified: February 2009
This open label, non-interventional study is to show the efficacy of Crestor (rosuvastatin) in reduction of LDL-cholesterol and cardiovascular risk parameters in patients with hypercholesterolemia. Effectiveness is to be evaluated using the difference in LDL cholesterol level between the first and the second visit after 12 weeks.


Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Open-Label Non-Interventional Evaluation of Efficacy of Crestor® (Rosuvastatin) in Reduction of LDL-Cholesterol and Cardiovascular Risk Parameters in Patients With Hypercholesterolaemia

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • LDL-cholesterol reduction [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • achievement of target levels of total cholesterol and LDL-cholesterol [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • patient compliance [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • change in coronary risk [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 602
Study Start Date: January 2007
Study Completion Date: October 2007

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients (outpatient or hospitalised) in whom Crestor is indicated according to the current Summary of product characteristics (SPC)

Inclusion Criteria:

  • a patient with hypercholesterolemia who has been prescribed Crestoraccording to physician's judgement, irrespective of the inclusion in the study.
  • no treatment with any statin in the last 3 months

Exclusion Criteria:

  • hypersensitivity to rosuvastatin or any other ingredient of Crestor
  • active liver disease, severe renal insufficiency
  • myopathy or predisposing risk factors for myopathy/ rhabdomyolysis
  • woman of child-bearing potential and not using appropriate contraceptive measures, pregnancy or lactation
  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 identifier: NCT00837083

Sponsors and Collaborators
Principal Investigator: Matija Cevc, MD University Medical Centre Ljubljana
  More Information

Responsible Party: Meta Jeras; Regulatory and Medical Affairs Manager, AstraZeneca Identifier: NCT00837083     History of Changes
Other Study ID Numbers: NIS-CSI-CRE-2006/1  NIS-CRE 01/06 
Study First Received: February 4, 2009
Last Updated: February 5, 2009
Health Authority: Slovenia: Agency for Medicinal Products - Ministry of Health

Keywords provided by AstraZeneca:

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Rosuvastatin Calcium
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents processed this record on December 02, 2016