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
  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:


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
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: 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 October 16, 2014