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

This study has been completed.
Sponsor:
Information provided by:
AOP Orphan Pharmaceuticals AG
ClinicalTrials.gov Identifier:
NCT01065038
First received: February 8, 2010
Last updated: October 5, 2010
Last verified: September 2005

February 8, 2010
October 5, 2010
September 2002
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Complete list of historical versions of study NCT01065038 on ClinicalTrials.gov Archive Site
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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

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.

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Interventional
Phase 3
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Essential Thrombocythaemia
  • Drug: Anagrelide
  • Drug: Hydroxyurea
  • Experimental: Anagrelide
    Intervention: Drug: Anagrelide
  • Active Comparator: Hydroxyurea
    Intervention: Drug: Hydroxyurea
Gisslinger H, Gotic M, Holowiecki J, Penka M, Thiele J, Kvasnicka HM, Kralovics R, Petrides PE; ANAHYDRET Study Group. Anagrelide compared with hydroxyurea in WHO-classified essential thrombocythemia: the ANAHYDRET Study, a randomized controlled trial. Blood. 2013 Mar 7;121(10):1720-8. doi: 10.1182/blood-2012-07-443770. Epub 2013 Jan 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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Inclusion Criteria:

  • Presence of essential thrombocythaemia with high-risk profile.

Exclusion Criteria:

  • previous treatment with cytoreductive drugs or Anagrelide
  • pregnant women or women in childbearing age with inadequate contraception
  • patients with contraindications for study drugs due to anaphylactoid reactions to either active or non-active ingredients
  • known lactose intolerance
  • cardiovascular diseases grade III-IV (Toxicity Criteria of the South West Oncology Group, 1992) - with a negative benefit/risk ratio
  • severe renal disease (Creatinin Clearance < 30 ml/min)
  • severe liver disease (AST or ALT > 5-times normal)
  • coexisting, malignant, systemic diseases
Both
18 Years and older
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Contact information is only displayed when the study is recruiting subjects
Austria,   Czech Republic,   France,   Germany,   Hungary,   Italy,   Lithuania,   Poland,   Singapore,   Slovenia
 
NCT01065038
AOP03007
Yes
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AOP Orphan Pharmaceuticals AG
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AOP Orphan Pharmaceuticals AG
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP