NCT00202644

A Study of Anagrelide and Hydroxyurea in High-Risk Essential Thrombocythemia Patients

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Essential thrombocythaemia is a disorder of bone marrow, which causes too many platelets to be produced. Platelets are small cells carried around in the blood, which help form blood clots. When patients have too many platelets, there is a risk of blood clots forming unnecessarily and excessive bleeding. The aim of this study is to gain additional information on the safety profile of Anagrelide (Xagrid(r)) and Hydroxyurea (also known as hydroxycarbamide).

Conditions

• Thrombocythemia, Hemorrhagic

Interventions

Type	Name	Description
DRUG	Anagrelide	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.
DRUG	Hydroxyurea	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.

Timeline

• Start date: 2006-01-13
• Primary completion: 2015-12-15
• Completion: 2015-12-15
• First posted: 2005-09-20
• Last updated: 2021-06-02
• Results posted: 2018-01-24

Locations

15 sites across 6 countries: Bulgaria, France, Hungary, Poland, Portugal, Serbia