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

This study has been completed.
Information provided by:
Shire Identifier:
First received: December 19, 2006
Last updated: June 6, 2014
Last verified: July 2010

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

Condition Intervention Phase
Essential Thrombocythaemia Drug: anagrelide hydrochloride Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:

Further study details as provided by Shire:

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

  • Tmax of Active Metabolite [ Time Frame: over 1 day ]
  • AUC of Active Metabolite [ Time Frame: over 1 day ]
  • T 1/2 of Active Metabolite [ Time Frame: over 1 day ]
  • CL/F of Active Metabolite [ Time Frame: over 1 day ]
  • Vz/F of Active Metabolite [ Time Frame: over 1 day ]

Secondary Outcome Measures:
  • Platelet Count [ Time Frame: over 1 day ]
    Platelet counts in patients with ET receiving Agrylin

  • Heart Rate [ Time Frame: over 1 day ]
    Heart rates in patients with ET receiving Agrylin

  • Systolic Blood Pressure [ Time Frame: over 1 day ]
    Systolic blood pressures in patients with ET receiving Agrylin

  • Diastolic Blood Pressure [ Time Frame: over 1 day ]
    Diastolic blood pressures in patients with ET receiving Agrylin

Enrollment: 24
Study Start Date: August 2006
Study Completion Date: March 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: anagrelide hydrochloride
Anagrelide hydrochloride 0.5 mg per capsule; patients will be stable on an anagrelide treatment regimen and will take capsules from their own prescription except on the PK day when the patient specific anagrelide dose will be administered from a controlled study specific supply.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00413634

Hospitl Del Mar
Barcelona, Spain
Quintiles Hermelinen
Sandviksgatan, Lulea, Sweden
Quintiles AB Phase I Unit
Strandbodgatan, Uppsala, Sweden
Uppsala Akademiska Sjukhus
Uppsala, Sweden, 75185
United Kingdom
Belfast City Hospital
Belfast, United Kingdom
Sponsors and Collaborators
Principal Investigator: Carlos Besses Raebel Spain
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Timothy Whitaker, M.D., Shire Identifier: NCT00413634     History of Changes
Other Study ID Numbers: SPD422-203
2004-004058-20 ( EudraCT Number )
Study First Received: December 19, 2006
Results First Received: March 5, 2009
Last Updated: June 6, 2014

Additional relevant MeSH terms:
Thrombocythemia, Essential
Blood Platelet Disorders
Hematologic Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Blood Coagulation Disorders
Hemorrhagic Disorders
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors processed this record on June 22, 2017