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

• Sponsor: AOP Orphan Pharmaceuticals AG (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01065038
• Collaborator: (none)
• Locations: 24
• Arms: 2

Study Details

Study Description

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

Study Design

• 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
• Study Start Date: Sep 1, 2002

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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

Locations

	Site	City	State	Country	Postal Code
1	Center Innsbruck	Innsbruck	Tirol	Austria	6020
2	Center AKH	Vienna		Austria	1090
3	Center Hanusch	Vienna		Austria	1140
4	Center Brno	Brno		Czech Republic	62500
5	Center Olomouc	Olomouc		Czech Republic	77520
6	Center Praha	Prague		Czech Republic	12808
7	Center Paris	Paris	CLICHY Cedex	France	92118
8	Center Munich	Munich	Bavaria	Germany	80331
9	Center Berlin	Berlin		Germany	12200
10	Center Halle	Halle		Germany	06111
11	Center Saarbrücken	Saarbrücken		Germany	66113
12	Center Ulm	Ulm		Germany	89081
13	Center Budapest	Budapest		Hungary	1097
14	Center Modena	Modena		Italy	41100
15	Center Pavia	Pavia		Italy	27100
16	Center Vilnius	Vilnius		Lithuania	2600
17	Center Gdansk	Gdansk		Poland	80-211
18	Center Katowice	Katowice		Poland	40-027
19	Center Krakow	Krakow		Poland	31-501
20	Center Lodz	Lodz		Poland	93-510
21	Center Lublin	Lublin		Poland	20-079
22	Center Warszawa	Warszawa		Poland	02-097
23	Center Singapore	Singapore		Singapore	169608
24	Center Ljubljana	Ljubljana		Slovenia

Sponsors and Collaborators

• AOP Orphan Pharmaceuticals AG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01065038
• Other Study ID Numbers: AOP03007
• First Posted: Feb 9, 2010
• Last Update Posted: Oct 6, 2010
• Last Verified: Sep 1, 2005

• Additional relevant MeSH terms: Thrombocytosis; Thrombocythemia, Essential; Hydroxyurea; Anagrelide

Study Results

No Results Posted as of Oct 6, 2010