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Evaluation of Crestor® (Rosuvastatin) in Daily Practice

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00837083
First received: February 4, 2009
Last updated: February 5, 2009
Last verified: February 2009
History of Changes
  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:

MedlinePlus related topics: Cholesterol
U.S. FDA Resources

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
  Eligibility

Ages Eligible for Study:   18 Years and older
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)

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00837083

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

No publications provided

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
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:
hypercholesterolemia
cholesterol
LDL-cholesterol
rosuvastatin
Crestor

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

ClinicalTrials.gov processed this record on May 23, 2013