MedDataX Logo

Aliskiren or Amlodipine in Hypertensive Hemodialysed Patients

NCT ID: NCT01394770

Last Updated: 2012-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2012-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension Dialysis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

hypertension dialysis aliskiren amlodipine outcome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Aliskiren

Group Type EXPERIMENTAL

Aliskiren

Intervention Type DRUG

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

Amlodipine

Group Type ACTIVE_COMPARATOR

Aliskiren

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Rasilez, Norvasc

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

IRCCS San Raffaele

OTHER

Sponsor Role collaborator

University of Campania Luigi Vanvitelli

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Gennaro Cice

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Second Univesity of Naples

Naples, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 33000470 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AL-AM dial

Identifier Type: -

Identifier Source: org_study_id