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

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: December 12, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
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.

Hypercholesterolemia Coronary Heart Disease Peripheral Vascular Disease CVA Diabetes

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Evaluation of the Efficacy of Rosuvastatin in Daily Practice in Untreated High Risk Patients (CHALLENGE)

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Enrollment: 2660
Study Start Date: September 2003

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00574782

Sponsors and Collaborators
Study Chair: Ingrid van Geel CV
Study Chair: Ingeborg Vosjan CV
  More Information Identifier: NCT00574782     History of Changes
Other Study ID Numbers: NL950057
Study First Received: December 12, 2007
Last Updated: December 12, 2007

Keywords provided by AstraZeneca:
cholesterol, coronary heart disease
LDL-C goal

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Arterial Occlusive Diseases
Rosuvastatin Calcium
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents processed this record on September 20, 2017