Overview

This trial is active, not recruiting.

Conditions hypertension, dialysis
Treatment aliskiren
Phase phase 4
Sponsor Second University of Naples
Collaborator IRCCS San Raffaele
Start date September 2009
End date September 2012
Trial size 350 participants
Trial identifier NCT01394770, AL-AM dial

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver)
Primary purpose treatment
Arm
(Experimental)
aliskiren Rasilez, Norvasc
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
(Active Comparator)
aliskiren Rasilez, Norvasc
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

Primary Outcomes

Measure
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 Outcomes

Measure
composite end-point of: all-cause hospitalization, new-onset heart failure,new-onset atrial fibrillation
time frame: 30 months

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Cardiovascular Events in Hypertensive Hemodialysed Patients: Aliskiren Versus Amlodipine. A Randomized, Double-blind Study.
Trial information was received from ClinicalTrials.gov and was last updated in July 2012.
Information provided to ClinicalTrials.gov by Second University of Naples.