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

Essential Thrombocythaemia Clinical Trial

Official title: 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

Status Completed

Clinical Trial Summary

Study AOP 03-007 was designed as a pivotal study to test, if Anagrelide (Thromboreductin®)was not inferior to HU with respect to efficacy in patients with ET. This approach to demonstrate non-inferiority was based on the following decision points:

• ET is a rare disease and recruitment of large patient number (> 1600) to prove superiority was not considered possible.

. It was decided to recruit only treatment naïve high risk patients to avoid pre-treatment bias, which further limited the number of patients eligible for the study.

Clinical Trial Description

n/a

Study Design

N/A

Related Conditions & MeSH terms

• Essential Thrombocythaemia
• Thrombocythemia, Essential
• Thrombocytosis

• NCT number: NCT01065038
• Study type: Interventional
• Source: AOP Orphan Pharmaceuticals AG
• Status: Completed
• Phase: Phase 3
• Start date: September 2002