NCT01394770

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P50-P75 for phase_4 hypertension

Timeline
Completed

Started Sep 2009

Typical duration for phase_4 hypertension

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 14, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

July 10, 2012

Status Verified

July 1, 2012

Enrollment Period

3 years

First QC Date

July 13, 2011

Last Update Submit

July 9, 2012

Conditions

HypertensionDialysis

Keywords

hypertensiondialysisaliskirenamlodipineoutcome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • composite end-point of: all-cause hospitalization, new-onset heart failure,new-onset atrial fibrillation

    30 months

Study Arms (2)

Aliskiren

EXPERIMENTAL
Drug: Aliskiren

Amlodipine

ACTIVE COMPARATOR
Drug: Aliskiren

Interventions

AliskirenDRUG

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

Also known as: Rasilez, Norvasc
AliskirenAmlodipine

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • hemodialysed patients
  • predialytic blood pressure greater or equal to 140/90 mmHg

You may not qualify if:

  • history of heart failure
  • history of ischemic heart disease
  • severe aortic stenosis
  • known allergy to aliskiren or amlodipine
  • severe disorders of liver function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Univesity of Naples

Naples, 80100, Italy

Location

Related Publications (1)

  • Mugendi GA, Mutua FM, Natale P, Esterhuizen TM, Strippoli GF. Calcium channel blockers for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2020 Oct 1;10(10):CD011064. doi: 10.1002/14651858.CD011064.pub2.

    PMID: 33000470DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

aliskirenAmlodipine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 13, 2011

First Posted

July 14, 2011

Study Start

September 1, 2009

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

July 10, 2012

Record last verified: 2012-07

Locations

IT(1)