NCT01395199

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

Amlodipine in the Prevention and Treatment of Iron Overload in Patients With Thalassemia Major: a Randomized, Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: University of Campinas, Brazil · Academic / Other
• Sex: All
• Age: 6 Years – 80 Years
• Healthy volunteers: Not accepted

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

• Thalassemia
• Iron Overload

Interventions

Type	Name	Description
DRUG	Amlodipine	5mg PO initially; may be reduced to 2.5mg PO if side effects

Timeline

• Start date: 2012-08-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2011-07-15
• Last updated: 2015-09-09

Locations

1 site across 1 country: Brazil