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

Diabetes Clinical Trial

— CHALLENGE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00574782
• Other study ID #: NL950057
• Status: Completed
• Phase: N/A
• First received: December 12, 2007
• Last updated: December 12, 2007
• Start date: September 2003

Study information

• Verified date: December 2007
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Not required:
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2660
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• CVA
• Diabetes
• Heart Diseases
• Hypercholesterolemia
• Myocardial Ischemia
• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca