Aliskiren or Amlodipine in Hypertensive Hemodialysed Patients

Phase 4

• Conditions: Hypertension; Dialysis
• Interventions: Drug: Aliskiren

• Registration Number: NCT01394770
• Lead Sponsor: University of Campania "Luigi Vanvitelli"

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 available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2011-07-13
• Study First Submitted QC: 2011-07-13
• Study First Posted: 2011-07-14
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-09
• Last Update Posted: 2012-07-10
• Primary Completion: 2012-09
• Study Completion: 2012-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aliskiren	Aliskiren	-
Amlodipine	Aliskiren	-

Primary Outcome Measures

Name	Time	Method
composite end-point of: all-cause mortality; cardiac event including myocardial infarction, need for coronary angioplasty or coronary bypass surgery, ischaemic stroke	30 months

Secondary Outcome Measures

Name	Time	Method
composite end-point of: all-cause hospitalization, new-onset heart failure,new-onset atrial fibrillation	30 months

Trial Locations

Locations (1)

Second Univesity of Naples; 🇮🇹 Naples, Italy