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.
Information provided by (Responsible Party):
First received: June 30, 2006
Last updated: August 29, 2011
Last verified: August 2011
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.
||Observational Model: Case-Only
Time Perspective: Prospective
||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.
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
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
||AstraZeneca Netherlands Medical Director, MD
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 30, 2006
||August 29, 2011
||Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Keywords provided by AstraZeneca:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 18, 2014
Lipid Metabolism Disorders