146
Participants
Start Date
December 31, 2010
Primary Completion Date
January 31, 2015
Study Completion Date
January 31, 2015
Anagrelide retard
"Week 1:~1x1 tablet/d of Anagrelide retard (1 tablet = 2mg; total dose = 2mg/d) will be administered in week 1.~Week 2 Anagrelide retard: Dosing will be titrated up according to response (platelet reduction) to 4 mg/day (=2x1 tablet) in week 2.~Week 3 - Week 4 Anagrelide retard In week 3 and 4, dose will either be increased or decreased to maintain platelets in the normal or close to normal range. The maximum dose is 4 tablets (=8mg Anagrelide) per day.~Maintenance Phase Anagrelide retard During maintenance phase (month 2 - month 12) doses of treatment are adjusted at the highest tolerated level which is able to maintain the platelet count within the normal range."
Placebo
"Week 1:~1. x1 tablet/d of placebo will be administered in week 1.~ Week 2~ Placebo:~2. x1 tablet/d of placebo will be administered in week 2.~Week 3 - Week 4~Placebo:~In week 3 and week 4 the maximum dose is 4 tablets per day.~Placebo:~In order to guarantee blinding of subjects the number of placebo tablets to be taken by the subject will vary during maintenance period:~Month 2 - month 3: 2x1 tablet/d Month 3 - month 6: 3x1 tablet/d Month 6 - month 9: 4x1 tablet/d Month 9 - month 12: 4x1 tablet/"
Uniklinik Innsbruck, Innsbruck
Universitätsklinik für Innere Medizin III, Universitätsklinikum Salzburg, Salzburg
Hanusch Krankenhaus, Vienna
Sozialmedizinisches Zentrum Ost, Vienna
Uniklinik für Innere Medizin I, Vienna
"University Multiprofile Hospital for Active Treatment Dr Georgi Stranski", Pleven
"University Multiprofile Hospital for Active Treatment Sveti Georgi", Plovdiv
"Multiprofile Hospital for Active Treatment, Tokuda Hospital Sofia", Sofia
National Specialized Hospital for Active Treatment of Hematological Diseases, Sofia
"SHAT Joan Pavel", Sofia
Clinical Hospital Dubrava, Zagreb
Kauno Medicinos Universiteto Klinikos, Kaunas
Klaipeda Hospital, Klaipėda
Uniwersyteckie Centrum Kliniczne, Gdansk
SP Szpital Kliniczny im. A. Mieleckiego, Katowice
Wojewódzki Szpital Specjalistyczny, Rzeszów
Specjalistyczny Szpital Miejski, Torùn
Klinika Hematologiczna, Instytut Hematologii i Transfuzjologii, Warsaw
Samodzielny Publiczny Centralny Szpital, Warsaw
"Clinical County Hospital Dr. Constantin Opris", Baia Mare
"Coltea Clinic Hospital", Bucharest
"Fundeni Clinical Institute", Bucharest
University Emergency Hospital, Bucharest
Emergency County Clinic Hospital, Sibiu
Emergency County Hospital Târgu Mureș, Târgu Mureş
State Medical Institution Territorial Clinical, Krasnodar
Haematology Research Center of RAMS, Moscow
Leningrad Regional Clinical Hospital, Saint Petersburg
Russian scientific Research Institute for Hematology and Transfusiology, Saint Petersburg
Saint Petersburg State Institution of Healthcare, Saint Petersburg
Yaroslavl Regional Clinical Hospital, Yaroslavl
University Hospital Bratislava, Bratislava
Institute of Urgent and Recovery Surgery n.a., Donetsk
Kmelnitskiy Regional Hospital, Khmelnitskiy
Institute of Haematology and Transfusiology, Kiev
Scientific Center of Radiation Medicine AMS of Ukraine, Kiev
Lviv Blood Pathology Institute, Lviv
Lead Sponsor
AOP Orphan Pharmaceuticals AG
INDUSTRY