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Completed

NCT Number: NCT00347217

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

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.

Completed

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Key information

Conditions

Hypercholesteremia Dyslipidemias Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, 's-Hertogenbosch, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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.

Important dates

Study start
2006
Study completion
2009
First posted
Jul 4, 2006
Registry last updated
Aug 30, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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