Cardiovascular Events in Hypertensive Hemodialysed Patients: Aliskiren Versus Amlodipine. A Randomized, Double-blind Study.

University of Campania "Luigi Vanvitelli"1 site in 1 country350 target enrollmentSeptember 2009

ConditionsHypertension Dialysis

InterventionsAliskiren

DrugsAliskiren

Overview

Phase: Phase 4
Intervention: Aliskiren
Conditions: Hypertension
Sponsor: University of Campania "Luigi Vanvitelli"
Enrollment: 350
Locations: 1
Primary Endpoint: composite end-point of: all-cause mortality; cardiac event including myocardial infarction, need for coronary angioplasty or coronary bypass surgery, ischaemic stroke
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2009

End Date

September 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Campania "Luigi Vanvitelli"

Responsible Party

Principal Investigator

Gennaro Cice

University of Campania "Luigi Vanvitelli"

Eligibility 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

Arms & Interventions

Aliskiren

Intervention: Aliskiren

Amlodipine

Intervention: Aliskiren

Outcomes

Primary Outcomes

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