search
Back to results

The Pharmacokinetics of Anagrelide in Elderly and Young Patients With Essential Thrombocythaemia (ET)

Primary Purpose

Essential Thrombocythaemia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
anagrelide hydrochloride
anagrelide hydrochloride
Sponsored by
Shire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Thrombocythaemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 < 5 mg/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.

Sites / Locations

  • Hospitl Del Mar
  • Quintiles Hermelinen
  • Uppsala Akademiska Sjukhus
  • Quintiles AB Phase I Unit
  • Belfast City Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Younger Participants (18-50 years)

Elderly Participants (≥65 years)

Arm Description

Outcomes

Primary Outcome Measures

Maximum Plasma Concentration (Cmax) of Agrylin
Time of Maximum Plasma Concentration (Tmax) of Agrylin
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Agrylin
Terminal Half-life (T 1/2) of Agrylin
Total Clearance (CL/F) of Agrylin
Volume of Distribution (Vz/F) of Agrylin
Cmax of Active Metabolite
An active metabolite has therapeutic activity similar to the parent compound and must be considered in therapeutic pharmacokinetics.
Tmax of Active Metabolite
AUC of Active Metabolite
T 1/2 of Active Metabolite
CL/F of Active Metabolite
Vz/F of Active Metabolite

Secondary Outcome Measures

Platelet Count
Platelet counts in patients with ET receiving Agrylin
Heart Rate
Heart rates in patients with ET receiving Agrylin
Systolic Blood Pressure
Systolic blood pressures in patients with ET receiving Agrylin
Diastolic Blood Pressure
Diastolic blood pressures in patients with ET receiving Agrylin

Full Information

First Posted
December 19, 2006
Last Updated
June 7, 2021
Sponsor
Shire
search

1. Study Identification

Unique Protocol Identification Number
NCT00413634
Brief Title
The Pharmacokinetics of Anagrelide in Elderly and Young Patients With Essential Thrombocythaemia (ET)
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
November 13, 2006 (Actual)
Primary Completion Date
January 22, 2008 (Actual)
Study Completion Date
January 22, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Thrombocythaemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Younger Participants (18-50 years)
Arm Type
Experimental
Arm Title
Elderly Participants (≥65 years)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
anagrelide hydrochloride
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
anagrelide hydrochloride
Intervention Description
Anagrelide hydrochloride 0.5 mg per capsule; participants will be stable on an anagrelide 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.
Primary Outcome Measure Information:
Title
Maximum Plasma Concentration (Cmax) of Agrylin
Time Frame
over 1 day
Title
Time of Maximum Plasma Concentration (Tmax) of Agrylin
Time Frame
over 1 day
Title
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Agrylin
Time Frame
over 1 day
Title
Terminal Half-life (T 1/2) of Agrylin
Time Frame
over 1 day
Title
Total Clearance (CL/F) of Agrylin
Time Frame
over 1 day
Title
Volume of Distribution (Vz/F) of Agrylin
Time Frame
over 1 day
Title
Cmax of Active Metabolite
Description
An active metabolite has therapeutic activity similar to the parent compound and must be considered in therapeutic pharmacokinetics.
Time Frame
over 1 day
Title
Tmax of Active Metabolite
Time Frame
over 1 day
Title
AUC of Active Metabolite
Time Frame
over 1 day
Title
T 1/2 of Active Metabolite
Time Frame
over 1 day
Title
CL/F of Active Metabolite
Time Frame
over 1 day
Title
Vz/F of Active Metabolite
Time Frame
over 1 day
Secondary Outcome Measure Information:
Title
Platelet Count
Description
Platelet counts in patients with ET receiving Agrylin
Time Frame
over 1 day
Title
Heart Rate
Description
Heart rates in patients with ET receiving Agrylin
Time Frame
over 1 day
Title
Systolic Blood Pressure
Description
Systolic blood pressures in patients with ET receiving Agrylin
Time Frame
over 1 day
Title
Diastolic Blood Pressure
Description
Diastolic blood pressures in patients with ET receiving Agrylin
Time Frame
over 1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 < 5 mg/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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Hospitl Del Mar
City
Barcelona
Country
Spain
Facility Name
Quintiles Hermelinen
City
Lulea
Country
Sweden
Facility Name
Uppsala Akademiska Sjukhus
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
Facility Name
Quintiles AB Phase I Unit
City
Uppsala
Country
Sweden
Facility Name
Belfast City Hospital
City
Belfast
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
22943924
Citation
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.
Results Reference
derived
Links:
URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020333s015lbl.pdf
Description
FDA-approved Label
URL
http://www.fda.gov/opacom/7alerts.html
Description
FDA Recall Information

Learn more about this trial

The Pharmacokinetics of Anagrelide in Elderly and Young Patients With Essential Thrombocythaemia (ET)

We'll reach out to this number within 24 hrs