Evaluation of the Efficacy of Rosuvastatin in Daily Practice in Untreated High Risk Patients (CHALLENGE) - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00574782

Purpose

In an observational multi-centre study (CHALLENGE), the effects were assessed of starting treatment with low doses of rosuvastatin in statin naive patients with a history of coronary heart disease (CHD), peripheral vascular disease (PVD), cerebrovascular accident (CVA), transient ischemic attack (TIA) or diabetes (DM), on low-density lipoprotein cholesterol (LDL-C) goal achievement. Also proportional changes in LDL-C, high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC), triglycerides (TG) and the ratio TC/HDL-C were studied.

Condition
Hypercholesterolemia Coronary Heart Disease Peripheral Vascular Disease CVA Diabetes

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol Coronary Artery Disease Diabetes Heart Diseases Peripheral Arterial Disease Vascular Diseases

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:	Evaluation of the Efficacy of Rosuvastatin in Daily Practice in Untreated High Risk Patients (CHALLENGE)

Further study details as provided by AstraZeneca:

Enrollment:	2660
Study Start Date:	September 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients eligible for the study were high-risk patients with a documented history of CHD, PVD, cerebrovascular atherosclerotic disease, DM II or DM I with microalbuminuria. LDL-C had to be > 2.5 mmol/l and the patient did not use any cholesterol lowering medication during the last 3 months preceding inclusion. The specialist made the decision to start treatment with rosuvastatin irrespective of study participation. Patient approved to place anonymous results at the disposal of AstraZeneca

Exclusion Criteria:

Exclusion criteria included patients familiar with muscular pain, myopathy or liver function disorders (inclusive elevation of serum transaminases), patients with familial dyslipideamia like familial hypercholesterolaemia and familial combined hyperlipid

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00574782

Sponsors and Collaborators

AstraZeneca

Investigators

Study Chair:	Ingrid van Geel	CV
Study Chair:	Ingeborg Vosjan	CV

More Information

Study ID Numbers:	NL950057
Study First Received:	December 12, 2007
Last Updated:	December 12, 2007
ClinicalTrials.gov Identifier:	NCT00574782
Health Authority:	Not required:

Keywords provided by AstraZeneca:

cholesterol, coronary heart disease
rosuvastatin
LDL-C goal
hypercholesterolemia

Study placed in the following topic categories:

Arterial Occlusive Diseases
Metabolic Diseases
Heart Diseases
Peripheral Vascular Diseases
Hyperlipidemias
Myocardial Ischemia
Vascular Diseases
Diabetes Mellitus
Ischemia

Arteriosclerosis
Coronary Disease
Rosuvastatin
Metabolic disorder
Hypercholesterolemia
Coronary Artery Disease
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents
Enzyme Inhibitors

Cardiovascular Diseases
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009