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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00347217
First received: June 30, 2006
Last updated: August 29, 2011
Last verified: August 2011
History of Changes
  Purpose

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 Phase
Hypercholesteremia
 Phase 4

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol Statins
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Estimated Enrollment: 3840
Study Start Date: February 2006
Study Completion Date: January 2009
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Clinic

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00347217

  Show 215 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Netherlands Medical Director, MD AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00347217     History of Changes
Other Study ID Numbers: NL401345, OPTIMAL
Study First Received: June 30, 2006
Last Updated: August 29, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on June 17, 2013