Anagrelide vs. Hydroxyurea - Efficacy and Tolerability Study in Patients With Essential Thrombocythaemia
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
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.