ClinicalTrials.Veeva

Menu

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

Shire logo

Shire

Status and phase

Completed
Phase 4

Conditions

Thrombocythemia, Hemorrhagic

Treatments

Drug: Anagrelide
Drug: Hydroxyurea

Study type

Interventional

Funder types

Industry

Identifiers

NCT00202644
SPD422-403
2004-004061-15 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment

150 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Confirmed diagnosis of essential thrombocythaemia - high risk profile
  • Previously untreated with a cytoreductive agent
  • Females of childbearing potential must have a negative urine pregnancy test prior to entering the study and must agree to use effective birth control for the duration of the study

Exclusion criteria

  • Diagnosis of any other myeloproliferative disorder
  • Any known cause for a secondary thrombocytosis
  • Anti-coagulant and anti-aggregant therapies
  • Known or suspected heart disease
  • Left Ventricular Ejection Fraction < 55%

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

150 participants in 2 patient groups

A
Experimental group
Treatment:
Drug: Anagrelide
B
Active Comparator group
Treatment:
Drug: Hydroxyurea

Trial contacts and locations

15

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems