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:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00347217
First received: June 30, 2006
Last updated: August 29, 2011
Last verified: August 2011
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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.
| 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:
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
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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 18, 2013