Aliskiren or Amlodipine in Hypertensive Hemodialysed Patients

University of Campania "Luigi Vanvitelli"

Status and phase: Unknown; Phase 4

Conditions: Hypertension; Dialysis

Treatments: Drug: Aliskiren

Study type: Interventional

Funder types: Other

Identifiers

NCT01394770

AL-AM dial

Details and patient eligibility

About

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.

Enrollment: 350 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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350 participants in 2 patient groups

Aliskiren

Experimental group

Treatment:

Drug: Aliskiren

Amlodipine

Active Comparator group

Treatment:

Drug: Aliskiren