Status:
COMPLETED
The Pharmacokinetics of Anagrelide in Elderly and Young Patients With Essential Thrombocythaemia (ET)
Lead Sponsor:
Shire
Conditions:
Essential Thrombocythaemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Age related differences in response to a drug could arise from variation in pharmacokinetic (PK) and/or pharmacodynamic (PD) profiles between age groups. Whilst the efficacy and safety profile of anag...
Eligibility Criteria
Inclusion
- Young patients aged 18-50 years inclusive or Elderly patients aged 65 years and over
- Patients must have a confirmed diagnosis of ET.
- Currently receiving anagrelide hydrochloride at a stable maintenance dose \< 5 mg/day for at least 4 weeks.
Exclusion
- Diagnosis of any other myeloproliferative disorder.
- Current use of tobacco in any form (e.g. smoking or chewing)
- Treatment with any known enzyme altering agents (barbiturates, phenothiazines, cimetidine etc.) within 30 days prior to or during the study.
- Patients for whom use of another cytoreductive agent in addition to anagrelide is considered necessary for control of platelet count.
Key Trial Info
Start Date :
November 13 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 22 2008
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00413634
Start Date
November 13 2006
End Date
January 22 2008
Last Update
June 29 2021
Active Locations (5)
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1
Hospitl Del Mar
Barcelona, Spain
2
Quintiles Hermelinen
Luleå, Sweden
3
Uppsala Akademiska Sjukhus
Uppsala, Sweden, 75185
4
Quintiles AB Phase I Unit
Uppsala, Sweden