Aliskiren or Amlodipine in Hypertensive Hemodialysed Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01394770
• Date of registration: 13/07/2011
• Prospective Registration: No
• Primary sponsor: Second University of Naples
• Public title: Aliskiren or Amlodipine in Hypertensive Hemodialysed Patients
• Scientific title: Cardiovascular Events in Hypertensive Hemodialysed Patients: Aliskiren Versus Amlodipine. A Randomized, Double-blind Study.
• Date of first enrolment: September 2009
• Target sample size: 350
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01394770
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Italy

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Hypertension

Dialysis

Intervention(s)

Drug: Aliskiren

Primary Outcome(s)

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]

Secondary Outcome(s)

composite end-point of: all-cause hospitalization, new-onset heart failure,new-onset atrial fibrillation [Time Frame: 30 months]

Secondary ID(s)

AL-AM dial

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

IRCCS San Raffaele