The Pharmacokinetics of Anagrelide in Elderly and Young Patients With Essential Thrombocythaemia (ET)
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.
2 other identifiers
interventional
24
3 countries
5
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 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Nov 2006
Shorter than P25 for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 13, 2006
CompletedFirst Submitted
Initial submission to the registry
December 19, 2006
CompletedFirst Posted
Study publicly available on registry
December 20, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 22, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 22, 2008
CompletedResults Posted
Study results publicly available
June 2, 2009
CompletedJune 29, 2021
June 1, 2021
1.2 years
December 19, 2006
March 5, 2009
June 7, 2021
Conditions
Outcome Measures
Primary Outcomes (12)
Maximum Plasma Concentration (Cmax) of Agrylin
over 1 day
Time of Maximum Plasma Concentration (Tmax) of Agrylin
over 1 day
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Agrylin
over 1 day
Terminal Half-life (T 1/2) of Agrylin
over 1 day
Total Clearance (CL/F) of Agrylin
over 1 day
Volume of Distribution (Vz/F) of Agrylin
over 1 day
Cmax of Active Metabolite
An active metabolite has therapeutic activity similar to the parent compound and must be considered in therapeutic pharmacokinetics.
over 1 day
Tmax of Active Metabolite
over 1 day
AUC of Active Metabolite
over 1 day
T 1/2 of Active Metabolite
over 1 day
CL/F of Active Metabolite
over 1 day
Vz/F of Active Metabolite
over 1 day
Secondary Outcomes (4)
Platelet Count
over 1 day
Heart Rate
over 1 day
Systolic Blood Pressure
over 1 day
Diastolic Blood Pressure
over 1 day
Study Arms (2)
Younger Participants (18-50 years)
EXPERIMENTALElderly Participants (≥65 years)
EXPERIMENTALInterventions
Anagrelide hydrochloride 0.5 mg per capsule; participants will be stable on an anagrelide treatment regimen and will take capsules from their own prescription except on the PK day when the participant specific anagrelide dose will be administered from a controlled study specific supply.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (5)
Hospitl Del Mar
Barcelona, Spain
Quintiles Hermelinen
Luleå, Sweden
Uppsala Akademiska Sjukhus
Uppsala, 75185, Sweden
Quintiles AB Phase I Unit
Uppsala, Sweden
Belfast City Hospital
Belfast, United Kingdom
Related Publications (1)
Besses C, Zeller W, Alvarez-Larran A, Coll R, Troy S, Purkayastha J, Martin P, Freitag C. Pharmacokinetics and tolerability of anagrelide hydrochloride in young (18 - 50 years) and elderly (>/= 65 years) patients with essential thrombocythemia. Int J Clin Pharmacol Ther. 2012 Nov;50(11):787-96. doi: 10.5414/CP201711.
PMID: 22943924DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Shire
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2006
First Posted
December 20, 2006
Study Start
November 13, 2006
Primary Completion
January 22, 2008
Study Completion
January 22, 2008
Last Updated
June 29, 2021
Results First Posted
June 2, 2009
Record last verified: 2021-06