Aliskiren or Amlodipine in Hypertensive Hemodialysed Patients

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01394770
• Other study ID #: AL-AM dial
• Status: Active, not recruiting
• Phase: Phase 4
• First received: July 13, 2011
• Last updated: July 9, 2012
• Start date: September 2009
• Est. completion date: September 2012

Study information

• Verified date: July 2012
• Source: Second University of Naples
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministery of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 350
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dialysis
• Hypertension

Intervention

Drug:
• Aliskiren
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

Locations

Country	Name	City	State
Italy	Second Univesity of Naples	Naples

Sponsors (2)

Lead Sponsor	Collaborator
Second University of Naples	IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	composite end-point of: all-cause mortality; cardiac event including myocardial infarction, need for coronary angioplasty or coronary bypass surgery, ischaemic stroke		30 months	Yes
Secondary	composite end-point of: all-cause hospitalization, new-onset heart failure,new-onset atrial fibrillation		30 months	Yes