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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00574782
First received: December 12, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
  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

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:

U.S. FDA Resources

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

No publications provided

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

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

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Hypercholesterolemia
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Hyperlipidemias
Dyslipidemias
 Lipid Metabolism Disorders
Metabolic Diseases
Atherosclerosis
Rosuvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013