Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00240331
First received: October 16, 2005
Last updated: May 17, 2011
Last verified: May 2011

October 16, 2005
May 17, 2011
January 2003
October 2008   (final data collection date for primary outcome measure)
Number of Randomised Participants With a Major Cardiovascular Event (Non-fatal Stroke, Non-fatal Myocardial Infarction or Cardiovascular Death) [ Time Frame: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years ] [ Designated as safety issue: No ]
Assessment of time to major cardiovascular event (combined endpoint of non-fatal stroke, non-fatal myocardial infarction or cardiovascular death).
Complete list of historical versions of study NCT00240331 on ClinicalTrials.gov Archive Site
  • Number of Randomised Participants That Died From Any Cause. [ Time Frame: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years ] [ Designated as safety issue: No ]
  • Number of Randomised Participants With a Major Cardiovascular Event or That Died From Any Known Cause [ Time Frame: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years ] [ Designated as safety issue: No ]
  • Number of Randomised Participants That Died From Cardiovascular Cause [ Time Frame: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years ] [ Designated as safety issue: No ]
  • Number of Randomised Participants That Died From Non Cardiovascular Cause [ Time Frame: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years ] [ Designated as safety issue: No ]
  • Number of Randomised Participants With an Atherosclerotic Cardiac Event (Non-fatal Myocardial Infarction or Coronary Heart Disease (CHD) Death) [ Time Frame: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years ] [ Designated as safety issue: No ]
  • Number of Randomised Participants That Experienced a Procedure as a Result of Stenosis or Thrombosis of the Vascular Access (Arteriovenous (AV) Fistulas and Grafts Only) for Haemodialysis. [ Time Frame: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years ] [ Designated as safety issue: No ]
  • Number of Randomised Participants That Experienced a Coronary or Peripheral Revascularisation (Including Above Ankle Limb Amputations). [ Time Frame: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years ] [ Designated as safety issue: No ]
  • - - To assess the safety of treatment
  • - To determine the cost due to hospitalisations (expressed as cost per life year saved)
  • - To determine the effect of treatment on the % changes in various cholesterol laboratory assessments
Not Provided
Not Provided
 
AURORA: Crestor 10mg Versus Placebo in Subjects With End-stage Renal Disease (ESRD)
A Study to Evaluate the Use of Rosuvastatin in Subjects On Regular Haemodialysis: an Assessment of Survival and Cardiovascular Events (AURORA). A Double Blind, Randomised, Phase 3b, Parallel-group Study to Compare the Effects of Rosuvastatin With Placebo on Assessment of Survival & Cardiovascular Events When Given to Subjects With End-stage Renal Failure on Chronic Haemodialysis Treatment

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
Renal Failure
  • Drug: 10mg Rosuvastatin
  • Drug: Placebo
  • Experimental: Rosuvastatin 10mg
    Intervention: Drug: 10mg Rosuvastatin
  • Placebo Comparator: Placebo
    matching Placebo
    Intervention: Drug: Placebo
Fellström BC, Jardine AG, Schmieder RE, Holdaas H, Bannister K, Beutler J, Chae DW, Chevaile A, Cobbe SM, Grönhagen-Riska C, De Lima JJ, Lins R, Mayer G, McMahon AW, Parving HH, Remuzzi G, Samuelsson O, Sonkodi S, Sci D, Süleymanlar G, Tsakiris D, Tesar V, Todorov V, Wiecek A, Wüthrich RP, Gottlow M, Johnsson E, Zannad F; AURORA Study Group. Rosuvastatin and cardiovascular events in patients undergoing hemodialysis. N Engl J Med. 2009 Apr 2;360(14):1395-407. Epub 2009 Mar 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2776
October 2008
October 2008   (final data collection date for primary outcome measure)

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
Both
50 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Czech Republic,   Denmark,   Finland,   France,   Germany,   Greece,   Hungary,   Iceland,   Ireland,   Italy,   Korea, Republic of,   Mexico,   Netherlands,   Norway,   Poland,   Sweden,   Switzerland,   Turkey,   United Kingdom
 
NCT00240331
4522IL/0096, D3562C00096
Not Provided
MSD, AstraZeneca
AstraZeneca
Not Provided
Study Director: AstraZeneca Crestor Medical Sciences Director, MD AstraZeneca
AstraZeneca
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP