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Trial record 1 of 1 for:    SPD422-203
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The Pharmacokinetics of Anagrelide in Elderly and Young Patients With Essential Thrombocythaemia (ET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00413634
Recruitment Status : Completed
First Posted : December 20, 2006
Results First Posted : June 2, 2009
Last Update Posted : June 12, 2014
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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

Condition or disease Intervention/treatment Phase
Essential Thrombocythaemia Drug: anagrelide hydrochloride Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : August 2006
Actual Primary Completion Date : January 2008
Actual Study Completion Date : March 2008

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Maximum Plasma Concentration (Cmax) of Agrylin [ Time Frame: over 1 day ]
  2. Time of Maximum Plasma Concentration (Tmax) of Agrylin [ Time Frame: over 1 day ]
  3. Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Agrylin [ Time Frame: over 1 day ]
  4. Terminal Half-life (T 1/2) of Agrylin [ Time Frame: over 1 day ]
  5. Total Clearance (CL/F) of Agrylin [ Time Frame: over 1 day ]
  6. Volume of Distribution (Vz/F) of Agrylin [ Time Frame: over 1 day ]
  7. 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.

  8. Tmax of Active Metabolite [ Time Frame: over 1 day ]
  9. AUC of Active Metabolite [ Time Frame: over 1 day ]
  10. T 1/2 of Active Metabolite [ Time Frame: over 1 day ]
  11. CL/F of Active Metabolite [ Time Frame: over 1 day ]
  12. Vz/F of Active Metabolite [ Time Frame: over 1 day ]

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

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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00413634

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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
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Principal Investigator: Carlos Besses Raebel Spain
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Timothy Whitaker, M.D., Shire Identifier: NCT00413634    
Other Study ID Numbers: SPD422-203
2004-004058-20 ( EudraCT Number )
First Posted: December 20, 2006    Key Record Dates
Results First Posted: June 2, 2009
Last Update Posted: June 12, 2014
Last Verified: July 2010
Additional relevant MeSH terms:
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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