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Evaluation of Crestor® (Rosuvastatin) in Daily Practice

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00837083
First Posted: February 5, 2009
Last Update Posted: February 6, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  Purpose
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.

Condition
Hypercholesterolemia

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 ]

Secondary Outcome Measures:
  • achievement of target levels of total cholesterol and LDL-cholesterol [ Time Frame: 12 weeks ]
  • patient compliance [ Time Frame: 12 weeks ]
  • change in coronary risk [ Time Frame: 12 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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)
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00837083


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

Responsible Party: Meta Jeras; Regulatory and Medical Affairs Manager, AstraZeneca
ClinicalTrials.gov Identifier: NCT00837083     History of Changes
Other Study ID Numbers: NIS-CSI-CRE-2006/1
NIS-CRE 01/06
First Submitted: February 4, 2009
First Posted: February 5, 2009
Last Update Posted: February 6, 2009
Last Verified: February 2009

Keywords provided by AstraZeneca:
hypercholesterolemia
cholesterol
LDL-cholesterol
rosuvastatin
Crestor

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors