A Phase II Study of the Pharmacokinetics of Anagrelide in Elderly and Young ET Patients
Information source: Shire Pharmaceutical Development
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Essential Thrombocythaemia
Intervention: anagrelide hydrochloride (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Shire Pharmaceutical Development Official(s) and/or principal investigator(s):
Carlos Besses Raebel, Principal Investigator, Affiliation: Spain
Overall contact:
Shire Call Center, Phone: +1 866 842 5335
Summary
Age related differences in response to a drug could arise from variation in PK and/or
pharmacodynamic (PD) profiles between age groups. Whilst the efficacy and safety profile of
anagrelide is well established through a well-documented clinical trial programme in patients
of all ages, no formal studies have been carried out to investigate whether the PK profile of
anagrelide and its metabolites is altered with age.
This study is designed to allow comparisons to be made in terms of pharmacokinetics of
anagrelide and its metabolites between elderly (>65 years) and young (18-50 years) ET
patients
Clinical Details
Official title: A Phase II, Open-Label, Multicentre, Pharmacokinetic, Pharmacodynamic and Safety Study of Anagrelide Hydrochloride in Young (18-50 Years) and Elderly (≥ 65 Years) Patients With Essential Thrombocythaemia.A Phase II, Open-Label, Multicentre, Pharmacokinetic, Pharmacodynamic and Safety Study of Anagrelide Hydrochloride in Young (18-50 Years) and Elderly (≥ 65 Years) Patients With Essential Thrombocythaemia
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacokinetics/Dynamics Study
Primary outcome: Single day PK assessments of anagrelide and metabolite.
Secondary outcome: Correlation of daily dose, anagrelide plasma concentrations and changes from baseline in platelet count.Correlation of plasma concentration of anagrelide and its active metabolite and heart rate and blood pressure. Safety and tolerability
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 <5mg/day for
at least 4 weeks.
Exclusion Criteria:
- 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.
Locations and Contacts
Shire Call Center, Phone: +1 866 842 5335
Hospitl Del Mar, Barcelona, Spain; Recruiting
Carlos Besses, Principal Investigator
Uppsala Akademiska Sjukhus, Uppsala 75185, Sweden; Recruiting
Professor G Birgegard, Phone: +46 18 6110000
Professor G Birgegard, Principal Investigator
Belfast City Hospital, Belfast, United Kingdom; Recruiting
Mary Frances McMullin, Principal Investigator
Quintiles Hermelinen, Sandviksgatan, Lulea, Sweden; Recruiting
Anders Henriksson
Anders Henriksson, Principal Investigator
Quintiles AB Phase I Unit, Strandbodgatan, Uppsala, Sweden; Recruiting
Jan Vouis
Jan Vouis, Principal Investigator
Additional Information
Starting date: August 2006
Ending date: April 2008
Last updated: January 8, 2008
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