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 is ongoing, but not recruiting participants.

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00347217

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 IV

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol Statins

Drug Information available for: Rosuvastatin Rosuvastatin calcium Cholest-5-en-3-ol (3beta)-

U.S. FDA Resources

Study Type:	Observational
Study Design:	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.

Further study details as provided by AstraZeneca:

Estimated Enrollment:	3840
Study Start Date:	February 2006

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Study ID Numbers:	NL401345, OPTIMAL
Study First Received:	June 30, 2006
Last Updated:	December 19, 2008
ClinicalTrials.gov Identifier:	NCT00347217
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

Study placed in the following topic categories:

Rosuvastatin
Metabolic Diseases
Hyperlipidemias
Neoplasm Metastasis

Metabolic disorder
Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on January 14, 2009