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

October 5, 2010 updated by: AOP Orphan Pharmaceuticals AG

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Center AKH
      • Vienna, Austria, 1140
        • Center Hanusch
    • Tirol
      • Innsbruck, Tirol, Austria, 6020
        • Center Innsbruck
  • Czech Republic
      • Brno, Czech Republic, 62500
        • Center Brno
      • Olomouc, Czech Republic, 77520
        • Center Olomouc
      • Prague, Czech Republic, 12808
        • Center Praha
  • France
    • CLICHY Cedex
      • Paris, CLICHY Cedex, France, 92118
        • Center Paris
  • Germany
      • Berlin, Germany, 12200
        • Center Berlin
      • Halle, Germany, 06111
        • Center Halle
      • Saarbrücken, Germany, 66113
        • Center Saarbrücken
      • Ulm, Germany, 89081
        • Center Ulm
    • Bavaria
      • Munich, Bavaria, Germany, 80331
        • Center Munich
  • Hungary
      • Budapest, Hungary, 1097
        • Center Budapest
  • Italy
      • Modena, Italy, 41100
        • Center Modena
      • Pavia, Italy, 27100
        • Center Pavia
  • Lithuania
      • Vilnius, Lithuania, 2600
        • Center Vilnius
  • Poland
      • Gdansk, Poland, 80-211
        • Center Gdansk
      • Katowice, Poland, 40-027
        • Center Katowice
      • Krakow, Poland, 31-501
        • Center Krakow
      • Lodz, Poland, 93-510
        • Center Lodz
      • Lublin, Poland, 20-079
        • Center Lublin
      • Warszawa, Poland, 02-097
        • Center Warszawa
  • Singapore
      • Singapore, Singapore, 169608
        • Center Singapore
  • Slovenia
      • Ljubljana, Slovenia
        • Center Ljubljana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anagrelide
Drug: Anagrelide
Active Comparator: Hydroxyurea
Drug: Hydroxyurea

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AOP Orphan Pharmaceuticals AG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Study Registration Dates

First Submitted

February 8, 2010

First Submitted That Met QC Criteria

February 8, 2010

First Posted (Estimate)

February 9, 2010

Study Record Updates

Last Update Posted (Estimate)

October 6, 2010

Last Update Submitted That Met QC Criteria

October 5, 2010

Last Verified

September 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOP03007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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