Anagrelide vs. Hydroxyurea - Efficacy and Tolerability Study in Patients With Essential Thrombocythaemia (ANAHYDRET)
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|ClinicalTrials.gov Identifier: NCT01065038|
Recruitment Status : Completed
First Posted : February 9, 2010
Last Update Posted : October 6, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Essential Thrombocythaemia||Drug: Anagrelide Drug: Hydroxyurea||Phase 3|
|Study Type :||Interventional (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|
|Study Start Date :||September 2002|
|Active Comparator: Hydroxyurea||
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01065038