Trials / Completed
CompletedNCT01065038
Anagrelide vs. Hydroxyurea - Efficacy and Tolerability Study in Patients With Essential Thrombocythaemia
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
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- AOP Orphan Pharmaceuticals AG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Anagrelide | |
| DRUG | Hydroxyurea |
Timeline
- Start date
- 2002-09-01
- First posted
- 2010-02-09
- Last updated
- 2010-10-06
Locations
24 sites across 10 countries: Austria, Czechia, France, Germany, Hungary, Italy, Lithuania, Poland, Singapore, Slovenia
Source: ClinicalTrials.gov record NCT01065038. Inclusion in this directory is not an endorsement.