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Study AOP 03-007 was designed as a pivotal study to test, if Anagrelide (Thromboreductin®) was not inferior to hydroxyurea (HU) with respect to efficacy in patients with essential thrombocythaemia (ET).
The Anahydret study is a single blind, multi-centre, randomised multinational Phase III Study to compare the Efficacy and Tolerability of Anagrelide vs Hydroxyurea in Patients with Essential Thrombocythaemia.
The Study starts with a screening visit (visit 1) followed by an induction phase (V2 - V6). During the induction phase, dosing (Anagrelide or Hydroxyurea) is increased or decreased (according to response).
During the maintenance phase (V7 - V14) doses of treatment are adjusted at the highest tolerated level which is able to maintain the platelet count within the normal range.
During maintenance phase efficacy and safety evaluations are performed.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)
AKH Wien University Clinic for Internal Medicine I, Department of Hematology
AOP Orphan Pharmaceuticals AG
Published on BioPortfolio: 2014-08-27T03:16:02-0400
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