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Aliskiren or Amlodipine in Hypertensive Hemodialysed Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01394770
Recruitment Status : Unknown
Verified July 2012 by Gennaro Cice, University of Campania "Luigi Vanvitelli".
Recruitment status was:  Active, not recruiting
First Posted : July 14, 2011
Last Update Posted : July 10, 2012
Sponsor:
Collaborator:
IRCCS San Raffaele
Information provided by (Responsible Party):
Gennaro Cice, University of Campania "Luigi Vanvitelli"

Tracking Information
First Submitted Date  ICMJE July 13, 2011
First Posted Date  ICMJE July 14, 2011
Last Update Posted Date July 10, 2012
Study Start Date  ICMJE September 2009
Estimated Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2011)
composite end-point of: all-cause mortality; cardiac event including myocardial infarction, need for coronary angioplasty or coronary bypass surgery, ischaemic stroke [ Time Frame: 30 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2011)
composite end-point of: all-cause hospitalization, new-onset heart failure,new-onset atrial fibrillation [ Time Frame: 30 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aliskiren or Amlodipine in Hypertensive Hemodialysed Patients
Official Title  ICMJE Cardiovascular Events in Hypertensive Hemodialysed Patients: Aliskiren Versus Amlodipine. A Randomized, Double-blind Study.
Brief Summary Hypertensive haemodialysis patients are at high risk for cardiovascular events. This study was undertaken to ascertain whether aliskiren, a direct renin inhibitor, compared with amlodipine, a calcium channel blocker, reduces mortality and cardiovascular events in these high-risk patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypertension
  • Dialysis
Intervention  ICMJE Drug: Aliskiren
Aliskiren 150 mg for 1 month with forced uptitration to 300 mg compared in parallel group with amlodipine 5 mg with forced uptitration to 10 mg
Other Name: Rasilez, Norvasc
Study Arms  ICMJE
  • Experimental: Aliskiren
    Intervention: Drug: Aliskiren
  • Active Comparator: Amlodipine
    Intervention: Drug: Aliskiren
Publications * Mugendi GA, Mutua FM, Natale P, Esterhuizen TM, Strippoli GF. Calcium channel blockers for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2020 Oct 1;10:CD011064. doi: 10.1002/14651858.CD011064.pub2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 13, 2011)
350
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2012
Estimated Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • hemodialysed patients
  • predialytic blood pressure greater or equal to 140/90 mmHg

Exclusion Criteria:

  • history of heart failure
  • history of ischemic heart disease
  • severe aortic stenosis
  • known allergy to aliskiren or amlodipine
  • severe disorders of liver function
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01394770
Other Study ID Numbers  ICMJE AL-AM dial
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gennaro Cice, University of Campania "Luigi Vanvitelli"
Study Sponsor  ICMJE University of Campania "Luigi Vanvitelli"
Collaborators  ICMJE IRCCS San Raffaele
Investigators  ICMJE Not Provided
PRS Account University of Campania "Luigi Vanvitelli"
Verification Date July 2012

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