A Study of Anagrelide and Hydroxyurea in High-Risk Essential Thrombocythemia Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00202644|
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : January 24, 2018
Last Update Posted : December 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Thrombocythemia, Hemorrhagic||Drug: Anagrelide Drug: Hydroxyurea||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase IIIb, Randomized, Open Label Study to Compare the Safety, Efficacy and Tolerability of Anagrelide Hydrochloride Versus Hydroxyurea in High-Risk Essential Thrombocythaemia Patients.|
|Actual Study Start Date :||January 13, 2006|
|Actual Primary Completion Date :||December 15, 2015|
|Actual Study Completion Date :||December 15, 2015|
Anagrelide hydrochloride 0.5mg capsules;initial dose administered will be 1.0mg/day administered as 0.5mg bid. The dose will be titrated such that the total daily dose is incremented by no more than 0.5mg per week as required depending on platelet reduction versus adverse event profile.
|Active Comparator: B||
Hydroxyurea is 500mg hydroxycarbamide capsules; initial dose is 1000mg/day, administered in two divided doses (500mg/dose). Dose titrated to effect to achieve a response.
- Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Over Time [ Time Frame: Baseline and Month 1, 2, 3, 6, 9, 12, 18, 24, 30 and 36 ]The LVEF was measured by echocardiography and considered a sufficiently sensitive measure to evaluate any changes in cardiac function.
- Platelet Count at Month 6 [ Time Frame: Month 6 ]Platelet count was evaluated.
- Change From Baseline in Platelet Counts at Month 3 and 36 [ Time Frame: Baseline and Month 3 and 36 ]Platelet count was evaluated throughout the study.
- Percentage of Participants With Complete Response [ Time Frame: Baseline up to Month 36 ]A complete response was defined as a platelet count of less than (<) 400x10^9/Liter which was confirmed over 2 consecutive visits at least 28 days apart.
- Percentage of Participants With Partial Response [ Time Frame: Baseline up to Month 36 ]A partial response is defined as a platelet count of 400-600 x 10^9/Liter and a reduction in platelet count of at least 200 x 10^9/Liter from baseline which was confirmed over 2 consecutive visits at least 28 days apart.
- Time to Complete Response [ Time Frame: Baseline up to Month 36 ]Time in days from the date of the first dose of study medication to the date of the first visit at which response was classified. If a participant did not achieve response then they were censored at their last visit in the study (Month 36 or withdrawal).
- Time to Partial Response [ Time Frame: Baseline up to Month 36 ]Time in days from the date of the first dose of study medication to the date of the first visit at which response was classified. If a participant did not achieve response then they were censored at their last visit in the study (Month 36 or withdrawal).
- Number of Participants With Thrombotic and Haemorrhagic Events [ Time Frame: From the signing of informed consent until the last study-related visit (Month 36) ]Thrombohaemorrhagic events are a well-known complication of the underlying essential thrombocythemia (ET) and disease progression. Events such as arterial and venous thrombosis, serious haemorrhage (including gastrointestinal haemorrhage), and death from vascular causes have been reported in participants who received cytoreductive treatment.
- Change From Baseline in White Blood Cell Count Over Time [ Time Frame: Baseline and Month 6, 12, 18, 24, 30 and 36 ]White blood cell count was evaluated throughout the study.
- Change From Baseline in Red Blood Cell Count Over Time [ Time Frame: Baseline and Month 6, 12, 18, 24, 30 and 36 ]Red blood cell count was evaluated throughout the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00202644
|University Multiprofile Hospital for Active Treatment ''Dr Georgi Stranski'' - Pleven|
|Pleven, Bulgaria, 5800|
|University Multiprofile Hospital for active Treatment ''Alexandrovska'' Clinic of Haematology|
|Sofia, Bulgaria, 1303|
|University Multiprofile Hospital for Active Treament ''Sv. Marina'' - Varna Haematology Clinic|
|Varna, Bulgaria, 9010|
|CHU Angers Services des Maladies du Sang|
|Angers, Cedex 09, France, 49933|
|Hopital Saint Louis - Centre d'Investigation Clinique|
|University of Debrecen Medical and Health Science Centre|
|Debrecen, Hungary, 4012|
|Petz Aladar County Teaching Hospital|
|Gyor, Hungary, 9024|
|Pandy Kalman Hospital of Bekes County|
|Gyula, Hungary, 5700|
|Kaposi Mor Teaching Hospital|
|Kaposvar, Hungary, 7400|
|Uniwersyteckie Centrum Kliniczne Katedra i Klinika Hematologii i Transplantologii|
|Gdansk, Poland, 80-952|
|Samodzielny Publiczny Szpital Kliniczny Nr 1|
|Lublin, Poland, 21-081|
|Katedra i Klinika Onkologii i Chorob Wewnetrznych Akademii Medycznej|
|Warsaw, Poland, 02-097|
|Klinika Hematologii Instytut Hematologii i Transfuzjologi|
|Warsaw, Poland, 02-776|
|Hospitals da Universidade de Coimbra|
|Coimbra, Portugal, 3000-076|
|Institute for Haematology of Clinical Centre of Serbia|
|Belgrade, Serbia, 11000|
|Study Director:||Study Director||Shire|