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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01065038
First Posted: February 9, 2010
Last Update Posted: October 6, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AOP Orphan Pharmaceuticals AG
  Purpose

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 Intervention Phase
Essential Thrombocythaemia Drug: Anagrelide Drug: Hydroxyurea Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by AOP Orphan Pharmaceuticals AG:

Study Start Date: September 2002
Arms Assigned Interventions
Experimental: Anagrelide Drug: Anagrelide
Active Comparator: Hydroxyurea Drug: Hydroxyurea

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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
Austria
Center Innsbruck
Innsbruck, Tirol, Austria, 6020
Center AKH
Vienna, Austria, 1090
Center Hanusch
Vienna, Austria, 1140
Czech Republic
Center Brno
Brno, Czech Republic, 62500
Center Olomouc
Olomouc, Czech Republic, 77520
Center Praha
Prague, Czech Republic, 12808
France
Center Paris
Paris, CLICHY Cedex, France, 92118
Germany
Center Munich
Munich, Bavaria, Germany, 80331
Center Berlin
Berlin, Germany, 12200
Center Halle
Halle, Germany, 06111
Center Saarbrücken
Saarbrücken, Germany, 66113
Center Ulm
Ulm, Germany, 89081
Hungary
Center Budapest
Budapest, Hungary, 1097
Italy
Center Modena
Modena, Italy, 41100
Center Pavia
Pavia, Italy, 27100
Lithuania
Center Vilnius
Vilnius, Lithuania, 2600
Poland
Center Gdansk
Gdansk, Poland, 80-211
Center Katowice
Katowice, Poland, 40-027
Center Krakow
Krakow, Poland, 31-501
Center Lodz
Lodz, Poland, 93-510
Center Lublin
Lublin, Poland, 20-079
Center Warszawa
Warszawa, Poland, 02-097
Singapore
Center Singapore
Singapore, Singapore, 169608
Slovenia
Center Ljubljana
Ljubljana, Slovenia
Sponsors and Collaborators
AOP Orphan Pharmaceuticals AG
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT01065038     History of Changes
Other Study ID Numbers: AOP03007
First Submitted: February 8, 2010
First Posted: February 9, 2010
Last Update Posted: October 6, 2010
Last Verified: September 2005

Additional relevant MeSH terms:
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