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Amlodipine as Adjuvant Treatment to Iron Chelation for Prevention of Cardiac Iron Overload in Thalassemia Patients

NCT02474420 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-10-26

No results posted yet for this study

Summary

This is a randomized, open label, two arms superiority trial of a representative population of patients with a primary diagnosis of transfusion dependent thalassemia with evidence of moderate cardiac iron overload, defined as an average T2\* MRI parameter at the mid inter-ventricular septum between 10 and 20ms.

Conditions

Interventions

DRUG

Amlodipine

amlodipine titrated up to 10 mg daily or maximum tolerated dose, whichever comes first

DRUG

Deferasirox

Deferasirox administered per standard of care by the treating physician

Sponsors & Collaborators

  • Kevin H.M. Kuo, MD, MSc, FRCPC

    lead OTHER

Principal Investigators

  • Kevin HM Kuo, MD MSc FRCPC · University Health Network, Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2017-06-30
Completion
2018-06-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02474420 on ClinicalTrials.gov