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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
Sponsor:
Information provided by:
AOP Orphan Pharmaceuticals AG

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.


Condition or disease Intervention/treatment Phase
Essential Thrombocythaemia Drug: Anagrelide Drug: Hydroxyurea Phase 3

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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


Arm Intervention/treatment
Experimental: Anagrelide Drug: Anagrelide
Active Comparator: Hydroxyurea Drug: Hydroxyurea




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

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

Information from the National Library of Medicine

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


Locations
Show Show 24 study locations
Sponsors and Collaborators
AOP Orphan Pharmaceuticals AG
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT01065038    
Other Study ID Numbers: AOP03007
First Posted: February 9, 2010    Key Record Dates
Last Update Posted: October 6, 2010
Last Verified: September 2005
Additional relevant MeSH terms:
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Thrombocytosis
Thrombocythemia, Essential
Blood Platelet Disorders
Hematologic Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Blood Coagulation Disorders
Hemorrhagic Disorders
Hydroxyurea
Anagrelide
Antineoplastic Agents
Antisickling Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Fibrinolytic Agents
Fibrin Modulating Agents
Platelet Aggregation Inhibitors