Aliskiren or Amlodipine in Hypertensive Hemodialysed Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Second University of Naples.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
IRCCS San Raffaele
Information provided by (Responsible Party):
Gennaro Cice, Second University of Naples
ClinicalTrials.gov Identifier:
NCT01394770
First received: July 13, 2011
Last updated: July 9, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Hypertension
Dialysis
Drug: Aliskiren
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Cardiovascular Events in Hypertensive Hemodialysed Patients: Aliskiren Versus Amlodipine. A Randomized, Double-blind Study.

Resource links provided by NLM:


Further study details as provided by Second University of Naples:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • composite end-point of: all-cause hospitalization, new-onset heart failure,new-onset atrial fibrillation [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 350
Study Start Date: September 2009
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aliskiren 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
Other Name: Rasilez, Norvasc
Active Comparator: Amlodipine 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
Other Name: Rasilez, Norvasc

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01394770

Locations
Italy
Second Univesity of Naples
Naples, Italy, 80100
Sponsors and Collaborators
Second University of Naples
IRCCS San Raffaele
  More Information

No publications provided

Responsible Party: Gennaro Cice, MD, Second University of Naples
ClinicalTrials.gov Identifier: NCT01394770     History of Changes
Other Study ID Numbers: AL-AM dial
Study First Received: July 13, 2011
Last Updated: July 9, 2012
Health Authority: Italy: Ministery of Health

Keywords provided by Second University of Naples:
hypertension
dialysis
aliskiren
amlodipine
outcome

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents

ClinicalTrials.gov processed this record on July 23, 2014