Evaluation of the Efficacy of Rosuvastatin in Daily Practice in Untreated High Risk Patients (CHALLENGE) (CHALLENGE)
December 12, 2007 updated by: AstraZeneca
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.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
2660
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Time Perspectives: Prospective
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Ingrid van Geel, CV
- Study Chair: Ingeborg Vosjan, CV
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2003
Study Registration Dates
First Submitted
December 12, 2007
First Submitted That Met QC Criteria
December 12, 2007
First Posted (Estimate)
December 17, 2007
Study Record Updates
Last Update Posted (Estimate)
December 17, 2007
Last Update Submitted That Met QC Criteria
December 12, 2007
Last Verified
December 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Metabolic Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Atherosclerosis
- Lipid Metabolism Disorders
- Hyperlipidemias
- Dyslipidemias
- Heart Diseases
- Coronary Artery Disease
- Myocardial Ischemia
- Coronary Disease
- Vascular Diseases
- Peripheral Arterial Disease
- Peripheral Vascular Diseases
- Hypercholesterolemia
Other Study ID Numbers
- NL950057
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.