Anagrelide vs. Hydroxyurea - Efficacy and Tolerability Study in Patients With Essential Thrombocythaemia (ANAHYDRET)
This study has been completed.
Sponsor:
AOP Orphan Pharmaceuticals AG
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
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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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
No publications provided by AOP Orphan Pharmaceuticals AG
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT01065038 History of Changes |
| Other Study ID Numbers: | AOP03007 |
| Study First Received: | February 8, 2010 |
| Last Updated: | October 5, 2010 |
| Health Authority: | Austria: Federal Ministry for Health and Women |
Additional relevant MeSH terms:
|
Thrombocythemia, Essential Thrombocytosis Blood Coagulation Disorders Hematologic Diseases Blood Platelet Disorders Myeloproliferative Disorders Bone Marrow Diseases Hemorrhagic Disorders Hydroxyurea Anagrelide Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Antisickling Agents Hematologic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Nucleic Acid Synthesis Inhibitors Fibrinolytic Agents Fibrin Modulating Agents Cardiovascular Agents Platelet Aggregation Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013