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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Thrombocyt

Brief 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.

Detailed Summary:
Sponsor: AOP Orphan Pharmaceuticals AG

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: AOP Orphan Pharmaceuticals AG

Dates:
Date Received: February 8, 2010
Date Started: September 2002
Date Completion:
Last Updated: October 5, 2010
Last Verified: September 2005