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Anagrelide vs. Hydroxyurea - Efficacy and Tolerability Study in Patients With Essential Thrombocythaemia

2014-08-27 03:16:02 | BioPortfolio

Summary

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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Conditions

Essential Thrombocythemia

Intervention

Anagrelide, Hydroxyurea

Location

AKH Wien University Clinic for Internal Medicine I, Department of Hematology
Vienna
Austria
1090

Status

Completed

Source

AOP Orphan Pharmaceuticals AG

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:02-0400

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