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Amlodipine for Iron Overload in Thalassemia Major
NCT01395199Phase 3
Key facts
- Status
- Completed
- Start
- Aug 2012
- Primary completion
- Feb 2015
- Countries
- 1
- Sponsor
- Universidade Estadual de Campinas
- Modality
- Small Molecules
- Drugs
- amlodipine
- Conditions
- iron overload
01
Overview
Phase 3, randomised, double-blind trial in iron overload comparing Amlodipine with Placebo (2 arms). Primary endpoint: Myocardial T2* values at 12 months. Started Aug 2012; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Amlodipine
Amlodipine 5mg QD + Standard Chelation
Placebo
Placebo + Standard Chelation
03
Who it enrols
Patients with thalassemia major aged 6 years or older undergoing stable iron chelation therapy, without severe heart failure (LVEF < 35%) or contraindications to MRI.
04
Endpoints
Primary
Myocardial T2* values
Secondary
Liver T2* values
Serum ferritin levels
Left ventricle volumes and function
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