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Amlodipine in the Prevention and Treatment of Iron Overload in Patients With Thalassemia Major

NCT01395199 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2015-09-09

No results posted yet for this study

Summary

This study aims to investigate the use of amlodipine, a drug that blocks the uptake of calcium into cells, in the prevention and treatment of iron overload in patients with thalassemia major. Since iron uses the same calcium channels to enter the heart, pancreas and other organs, blocking these channels might help to prevent the accumulation of iron in these tissues. The study will follow 60 patients with thalassemia major: 30 will receive amlodipine and 30 will serve as controls receiving placebo in a randomized double-blind fashion. Patients will be monitored through one year. Monitoring will occur through the measurement of blood ferritin as well as live and heart T2\* by MRI initially, at 6 and 12 months.

Conditions

Interventions

DRUG

Amlodipine

5mg PO initially; may be reduced to 2.5mg PO if side effects

Sponsors & Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

    collaborator OTHER_GOV

  • University of Campinas, Brazil

    lead OTHER

Principal Investigators

  • Juliano L Fernandes, MD, PhD · University of Campinas, Brazil

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • Brazil

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 NCT01395199 on ClinicalTrials.gov