Not Signed In -
Hydroxyurea |
Droxia; Hydrea |
Clinical Trial: A Study to Compare the Safety and Effectiveness of Anagrelide and Hydroxyurea in High-Risk Essential Thrombocythaemia Patients.
This study is not yet open for patient recruitment.
Verified by Shire Pharmaceutical Development September 2005
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
| Thrombocythemia, Hemorrhagic | Drug: Anagrelide | Phase IV |
MedlinePlus related topics: Bleeding Disorders; Blood and Blood Disorders; Bone Marrow Diseases
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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.
Further Study Details:
Primary Outcomes: Cardiovascular safety as assessed by echocardiography at 3 years.
Secondary Outcomes: Platelet counts; Cytoreductive impact on WBC and RBC lines; Tolerability; Incidence of disease related thrombotic and haemorrhagic events
Expected Total Enrollment: 184
Secondary Outcomes: Platelet counts; Cytoreductive impact on WBC and RBC lines; Tolerability; Incidence of disease related thrombotic and haemorrhagic events
Expected Total Enrollment: 184
Study start: October 2005
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
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%
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00202644
Carol Priestley +44 (0) 1959 54 2856
Study chairs or principal investigators
Marc Boogaerts, MD, Professor, Principal Investigator, U.Z. Gasthuisberg
More Information
Study ID Numbers: SPD422-403
Last Updated: September 19, 2005
Record first received: September 12, 2005
ClinicalTrials.gov Identifier: NCT00202644
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2005-09-20
Last Updated: September 19, 2005
Record first received: September 12, 2005
ClinicalTrials.gov Identifier: NCT00202644
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2005-09-20
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