Anagrelide vs. Hydroxyurea - Efficacy and Tolerability Study in Patients With Essential Thrombocythaemia
NCT ID: NCT01065038
Last Updated: 2010-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
INTERVENTIONAL
2002-09-30
Brief Summary
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• 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.
Detailed Description
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Conditions
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Study Groups
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Anagrelide
Anagrelide
Hydroxyurea
Hydroxyurea
Interventions
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Anagrelide
Hydroxyurea
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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AOP Orphan Pharmaceuticals AG
INDUSTRY
Locations
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Center Innsbruck
Innsbruck, Tyrol, Austria
Center AKH
Vienna, Vienna, Austria
Center Hanusch
Vienna, Vienna, Austria
Center Brno
Brno, , Czechia
Center Olomouc
Olomouc, , Czechia
Center Praha
Prague, , Czechia
Center Paris
Paris, Clichy Cedex, France
Center Munich
Munich, Bavaria, Germany
Center Berlin
Berlin, , Germany
Center Halle
Halle, , Germany
Center Saarbrücken
Saarbrücken, , Germany
Center Ulm
Ulm, , Germany
Center Budapest
Budapest, , Hungary
Center Modena
Modena, , Italy
Center Pavia
Pavia, , Italy
Center Vilnius
Vilnius, , Lithuania
Center Gdansk
Gdansk, , Poland
Center Katowice
Katowice, , Poland
Center Krakow
Krakow, , Poland
Center Lodz
Lodz, , Poland
Center Lublin
Lublin, , Poland
Center Warszawa
Warsaw, , Poland
Center Singapore
Singapore, , Singapore
Center Ljubljana
Ljubljana, , Slovenia
Countries
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References
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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.
Other Identifiers
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AOP03007
Identifier Type: -
Identifier Source: org_study_id