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Observational to Investigate the Efficacy of CRESTOR 5mg in Reaching LDL-C Target Goals in Patients Who Are at High Risk for a Cardiovascular Event

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. Identifier: NCT00347217
Recruitment Status : Completed
First Posted : July 4, 2006
Last Update Posted : August 30, 2011
Information provided by (Responsible Party):

Brief Summary:
Observational study to investigate the use and efficacy of CRESTOR 5 mg in reaching LDL-C target goals in both statin naïve and statin treated primary and secondary prevention patients at high risk for a cardiovascular event.

Condition or disease

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Study Type : Observational
Estimated Enrollment : 3840 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: An Observational Study Into the Usage and Efficacy of Crestor 5mg as a Start Dosage in Achieving the LDL-C Target Level in Both Statin-naive and Treated Primary and Secondary Prevention Patients With a High Risk of a Cardiovascular Event.
Study Start Date : February 2006
Actual Study Completion Date : January 2009

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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Inclusion Criteria:

  • The patient has a high risk of a cardiovascular event as defined by the European guidelines.
  • The patient is statin-naive (i.e. has not used a statin > 2 months), or is currently treated with atorvastatin, pravastatin or simvastatin.
  • An LDL-C level is known for the statin-naive patient or for the statin used during visit 1.
  • It has been decided to start the patient on CRESTOR 5 mg.
  • The patient is prepared to give permission to the coded data being made available to AstraZeneca

Exclusion Criteria:

  • The patient is known to have complaints of myalgia, myopathy or liver function impairment (including elevated levels of serum transaminases) where there is a causal relationship with the statin treatment.
  • Contraindications for treatment with CRESTOR (see 1 B1 text).
  • Patients with a family history of dyslipidemias, for instance familiar (combined) hypercholesterolemia

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 identifier (NCT number): NCT00347217

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Sponsors and Collaborators
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Study Director: AstraZeneca Netherlands Medical Director, MD AstraZeneca

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Responsible Party: AstraZeneca Identifier: NCT00347217     History of Changes
Other Study ID Numbers: NL401345
First Posted: July 4, 2006    Key Record Dates
Last Update Posted: August 30, 2011
Last Verified: August 2011

Keywords provided by AstraZeneca:
LDL-C goal
observational study
primary prevention
secondary prevention

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