A Phase IIIb, randomised, open label study to compare the safety, efficacy and tolerability of anagrelide hydrochloride versus hydroxyurea in high-risk essential thrombocythaemia patients.

Shire Pharmaceutical Development Ltd0 个研究点目标入组 146 人2006年12月13日

概览

暂无简介。

注册库

who.int

开始日期

2006年12月13日

结束日期

2015年12月15日

最后更新

2年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

•Patients must have given written informed consent to participate in the study.
•Patients must be aged \= 18 years.
•Previously untreated with a cytotreductive agent.
•Confirmed diagnosis of ET \- High Risk Profile.
•Satisfactory Medical assessment with no clinicallly significant and relevant abnormalities.
•If patients are female and of childbearing potential they must have a negative serum pregnancy test prior to entering the study and must agree to use effective birth control for the duration of the study. Pregnant or lactating women are excluded from participation.
•Patients must be able, willing and likely to comply with the study procedures and restrictions.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

•Patients with a diagnosis of any other myeloproliferative disorder (MPD).
•Any known cause for a secondary thrombocytosis.
•Previous or current treatment with cytoreductive therapy.
•Anti\-coagulant therapies.
•Anti\-aggregant therapies, including aspirin. (Aspirin or other anti\-aggregant therapy is allowed up to the point of randomisation).
•Known or suspected intolerance to study materials.
•Known or suspected Heart Disease.
•Left Ventricular Ejection Fraction (LVEF) \<55%.
•Treatment with any medications known to alter ventricular ejection fraction.
•Life threatening malignancy or neoplasia which in the opinion of the investigator is unrelated to thrombocythaemia.