Aliskiren or Amlodipine in Hypertensive Hemodialysed Patients

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

IRCCS San Raffaele

Information provided by (Responsible Party):

Gennaro Cice, Second University of Naples

ClinicalTrials.gov Identifier:

NCT01394770

First received: July 13, 2011

Last updated: July 9, 2012

Last verified: July 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	July 13, 2011
Last Updated Date	July 9, 2012
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 ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01394770 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	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	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) 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 Arm (s)	Experimental: Aliskiren Intervention: Drug: Aliskiren Active Comparator: Amlodipine Intervention: Drug: Aliskiren
Publications *	Not Provided
* 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	Active, not recruiting
Estimated Enrollment ^ICMJE	350
Estimated Completion Date	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
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Italy

Administrative Information
NCT Number ^ICMJE	NCT01394770
Other Study ID Numbers ^ICMJE	AL-AM dial
Has Data Monitoring Committee	No
Responsible Party	Gennaro Cice, Second University of Naples
Study Sponsor ^ICMJE	Second University of Naples
Collaborators ^ICMJE	IRCCS San Raffaele
Investigators ^ICMJE	Not Provided
Information Provided By	Second University of Naples
Verification Date	July 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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