A Phase II Study of the Pharmacokinetics of Anagrelide in Elderly and Young ET Patients - Full Text View

Sponsored by:	Shire Pharmaceutical Development
Information provided by:	Shire Pharmaceutical Development
ClinicalTrials.gov Identifier:	NCT00413634

Purpose

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

Condition	Intervention	Phase
Essential Thrombocythaemia	Drug: anagrelide hydrochloride	Phase II

Genetics Home Reference related topics: hemophilia

Drug Information available for: Anagrelide Anagrelide hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacokinetics/Dynamics Study
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

Further study details as provided by Shire Pharmaceutical Development:

Primary Outcome Measures:

Single day PK assessments of anagrelide and metabolite. [ Time Frame: over 1 day ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Correlation of daily dose, anagrelide plasma concentrations and changes from baseline in platelet count. [ Time Frame: over 1 day ] [ Designated as safety issue: No ]
Correlation of plasma concentration of anagrelide and its active metabolite and heart rate and blood pressure. [ Time Frame: over 1 day ] [ Designated as safety issue: Yes ]
Safety and tolerability [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated 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
1: Experimental	Drug: anagrelide hydrochloride Anagrelide hydrochloride 0.5mg 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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00413634

Locations

Spain
Hospitl Del Mar
Barcelona, Spain
Sweden
Uppsala Akademiska Sjukhus
Uppsala, Sweden, 75185
Sweden, Lulea
Quintiles Hermelinen
Sandviksgatan, Lulea, Sweden
Sweden, Uppsala
Quintiles AB Phase I Unit
Strandbodgatan, Uppsala, Sweden
United Kingdom
Belfast City Hospital
Belfast, United Kingdom

Sponsors and Collaborators

Shire Pharmaceutical Development

Investigators

Principal Investigator:

Carlos Besses Raebel

Spain

More Information

Responsible Party:	Shire ( Timothy Whitaker, M.D. )
Study ID Numbers:	SPD422-203
Study First Received:	December 19, 2006
Last Updated:	July 15, 2008
ClinicalTrials.gov Identifier:	NCT00413634
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency; Germany: Federal Institute for Drugs and Medical Devices; Sweden: Medical Products Agency; Spain: Ministry of Health

Study placed in the following topic categories:

Essential thrombocytosis
Hematologic Diseases
Blood Coagulation Disorders
Blood Platelet Disorders
Myeloproliferative Disorders
Hemostatic Disorders
Thrombocytopathy

Hemorrhagic Disorders
Hemorrhagic thrombocythemia
Thrombocytosis
Thrombocythemia, Hemorrhagic
Bone Marrow Diseases
Anagrelide

Additional relevant MeSH terms:

Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents

Platelet Aggregation Inhibitors
Fibrinolytic Agents
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009