Study in High Risk Patients Switched From Higher Doses of Other Statins to Crestor on the Percentage of Patients Reaching the New LDL-C Target Goal

This study has been completed.

First Received: October 16, 2005 Last Updated: February 6, 2008 History of Changes

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00240344

Purpose

The purpose of this study is to determine the efficacy of Crestor in high risk patients switched from higher doses of other statins in obtaining the new European Atherosclerosis Society (EAS) low-density lipoprotein cholesterol (LDL-C) guidelines.

Condition	Phase
Hypercholesterolemia	Phase IV

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol Statins

Drug Information available for: Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	REALISTIC: Protocol for an Observational Study in High Risk Patients Switched From Higher Doses of Other Statins to Crestor on the Percentage of Patients Reaching the New EAS LDL-C Target Goal

Further study details as provided by AstraZeneca:

Estimated Enrollment:	2650
Study Start Date:	September 2004
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

High risk patients
High doses of other statins
LDL-C known, starts with Crestor 10 mg
Permission to use patient data by AstraZeneca (AZ)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00240344

Show 75 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Netherlands Medical Director, MD

AstraZeneca

More Information

No publications provided

Study ID Numbers:	NL401142, REALISTIC
Study First Received:	October 16, 2005
Last Updated:	February 6, 2008
ClinicalTrials.gov Identifier:	NCT00240344 History of Changes
Health Authority:	European Union: European Medicines Agency

Keywords provided by AstraZeneca:

High risk patients
Crestor
Rosuvastatin
LDL cholesterol
observational

Study placed in the following topic categories:

Antimetabolites
Rosuvastatin
Metabolic Diseases
Hyperlipidemias
Antilipemic Agents
Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Metabolic Disorder
Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Enzyme Inhibitors
Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Rosuvastatin
Therapeutic Uses
Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009