AURORA: Crestor 10mg Versus Placebo in Subjects With End-stage Renal Disease (ESRD)

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Renal Failure

Treatments: Drug: Placebo; Drug: 10mg Rosuvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00240331

4522IL/0096

D3562C00096

Details and patient eligibility

About

The purpose of this study is to see if rosuvastatin helps to reduce the number of heart attacks, strokes and cardiovascular deaths in patients undergoing haemodialysis.

Enrollment: 2,776 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female subjects with end-stage renal failure aged 50-80 years, who have received regular haemodialysis treatment for at least 3 months

Exclusion criteria

• Subjects will have no underlying condition that is expected to limit survival to less than 1 year and is also unrelated to end-stage renal disease (ESRD). Subjects should not have received a statin therapy within the past 6 months

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2,776 participants in 2 patient groups, including a placebo group

Rosuvastatin 10mg

Experimental group

Treatment:

Drug: 10mg Rosuvastatin

Placebo

Placebo Comparator group

Description:

matching Placebo

Treatment:

Drug: Placebo