Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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
  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

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
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 ClinicalTrials.gov identifier: 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
Study First Received: February 4, 2009
Last Updated: February 5, 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
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents

ClinicalTrials.gov processed this record on April 27, 2017