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
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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:
ClinicalTrials.gov processed this record on March 03, 2015