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

Sponsored by:	Shire Pharmaceutical Development
Information provided by:	Shire Pharmaceutical Development
ClinicalTrials.gov Identifier:	NCT00202644

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 Drug: Hydroxyurea	Phase IV

Genetics Home Reference related topics: hemophilia

Drug Information available for: Anagrelide hydrochloride Anagrelide Hydroxyurea

U.S. FDA Resources

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 as provided by Shire Pharmaceutical Development:

Primary Outcome Measures:

Cardiovascular safety as assessed by echocardiography over 3 years. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Platelet counts during titration and long term [ Time Frame: 3 & 6 months and up to 3 years ] [ Designated as safety issue: No ]
Cytoreductive impact on WBC and RBC lines [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
Tolerability [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
Incidence of disease related thrombotic and haemorrhagic events [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	184
Study Start Date:	September 2005
Estimated Study Completion Date:	October 2012
Estimated Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	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.
B: Active Comparator	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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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%

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00202644

Contacts

Contact: Shire Call Center

+1 866-842-5335

Locations

Ireland
Tullamore General Hospital	Recruiting
Tullamore, Ireland

Sponsors and Collaborators

Shire Pharmaceutical Development

Investigators

Principal Investigator:

Marc Boogaerts, MD, Professor

U.Z. Gasthuisberg

More Information

No publications provided

Responsible Party:	Shire ( Timothy Whitaker, M.D. )
Study ID Numbers:	SPD422-403
Study First Received:	September 12, 2005
Last Updated:	January 7, 2009
ClinicalTrials.gov Identifier:	NCT00202644 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Hydroxyurea
Hematologic Diseases
Blood Coagulation Disorders
Blood Platelet Disorders
Myeloproliferative Disorders
Fibrinolytic Agents
Cardiovascular Agents
Hemostatic Disorders
Thrombocytopathy

Fibrin Modulating Agents
Hemorrhagic Disorders
Thrombocytosis
Thrombocythemia, Hemorrhagic
Hemorrhagic Thrombocythemia
Platelet Aggregation Inhibitors
Essential Thrombocytosis
Bone Marrow Diseases
Anagrelide

Additional relevant MeSH terms:

Antisickling Agents
Molecular Mechanisms of Pharmacological Action
Hematologic Diseases
Hydroxyurea
Antineoplastic Agents
Blood Coagulation Disorders
Blood Platelet Disorders
Hematologic Agents
Myeloproliferative Disorders
Fibrinolytic Agents
Enzyme Inhibitors

Cardiovascular Agents
Pharmacologic Actions
Fibrin Modulating Agents
Hemorrhagic Disorders
Therapeutic Uses
Thrombocytosis
Thrombocythemia, Hemorrhagic
Platelet Aggregation Inhibitors
Bone Marrow Diseases
Nucleic Acid Synthesis Inhibitors
Anagrelide

ClinicalTrials.gov processed this record on May 07, 2009