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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Patients must be aged ≥ 18 years. Male, or female patients who are postmenopausal, or surgically or biologically sterile. Females of childbearing potential with a negative urine pregnancy test prior to entering the study and using acceptable forms of contraception for the duration of the study.Satisfactory medical assessment with no clinically significant and relevant abnormalities. Diagnosis of essential thrombocythaemia. The patient must have given written personally signed and dated informed consent to participate in the study.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Concurrent disease 1. Known or suspected heart disease 2. Left ventricular ejection fraction (LVEF) <55% 3. History of life threatening malignancy or neoplasia, which in the opinion of the investigator is unrelated to thrombocythaemia 4. Moderate to severe renal impairment defined as creatinine clearance <50ml/min , or moderate to severe hepatic impairment defined as elevated transaminases >5x ULN 5. Clinically significant abnormal laboratory values (excluding markers of essential thrombocythaemia) will exclude the patient from the study as will known infection with hepatitis B, hepatitis C or HIV 6. Current or relevant previous history of serious, severe or unstable (acute or progressive) physical or psychiatric illness, any medical disorder that may require treatment or make the patient unlikely to fully complete the study, or any condition that presents undue risk from the study medication or procedures. Concomitant medications 1. Previous or current treatment with cytoreductive therapy 2. Anti-aggregant therapies, including aspirin. (Aspirin or other anti-aggregant therapy is allowed up to the point of randomisation) 3. Anticoagulant therapies 4. Treatment with any agents known to effect ventricular ejection fraction including but not limited to the following: positive inotropes, diuretics, anti-arrhythmic drugs, beta blockers, antihypertensives, drugs effecting the renin-angiotensin system, nitrates, calcium channel blockers, potassium channel activators, and sympathomimetics. Allergy / intolerance Known or suspected intolerance or hypersensitivity to the study materials [or closely related compounds] or any of their excipients. Substance abuse Patients with a history of alcohol or other substance abuse within the last 2-years will be excluded. Other clinical trials / experimental medications Patients must not have used another investigational agent or taken part in a clinical trial within the last 30-days prior to enrolment. Patients may however participate in study SPD422-203 whilst still enrolled in this study. Others Female patients who are pregnant or lactating including females with a positive pregnancy test at screening must be excluded. Patients that have previously been enrolled into this study and subsequently withdrawn must also be excluded.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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