The Pharmacokinetics of Anagrelide in Elderly and Young Patients With Essential Thrombocythaemia (ET)
This study has been completed.
Sponsor:
Shire Development LLC
Information provided by:
Shire Development LLC
ClinicalTrials.gov Identifier:
NCT00413634
First received: December 19, 2006
Last updated: July 20, 2010
Last verified: July 2010
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Purpose
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 Endpoint Classification: Pharmacokinetics/Dynamics Study 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 Development LLC:
Primary Outcome Measures:
- Maximum Plasma Concentration (Cmax) of Agrylin [ Time Frame: over 1 day ] [ Designated as safety issue: Yes ]
- Time of Maximum Plasma Concentration (Tmax) of Agrylin [ Time Frame: over 1 day ] [ Designated as safety issue: Yes ]
- Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Agrylin [ Time Frame: over 1 day ] [ Designated as safety issue: Yes ]
- Terminal Half-life (T 1/2) of Agrylin [ Time Frame: over 1 day ] [ Designated as safety issue: Yes ]
- Total Clearance (CL/F) of Agrylin [ Time Frame: over 1 day ] [ Designated as safety issue: Yes ]
- Volume of Distribution (Vz/F) of Agrylin [ Time Frame: over 1 day ] [ Designated as safety issue: Yes ]
- Cmax of Active Metabolite [ Time Frame: over 1 day ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]
- AUC of Active Metabolite [ Time Frame: over 1 day ] [ Designated as safety issue: Yes ]
- T 1/2 of Active Metabolite [ Time Frame: over 1 day ] [ Designated as safety issue: Yes ]
- CL/F of Active Metabolite [ Time Frame: over 1 day ] [ Designated as safety issue: Yes ]
- Vz/F of Active Metabolite [ Time Frame: over 1 day ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Platelet Count [ Time Frame: over 1 day ] [ Designated as safety issue: Yes ]Platelet counts in patients with ET receiving Agrylin
- Heart Rate [ Time Frame: over 1 day ] [ Designated as safety issue: Yes ]Heart rates in patients with ET receiving Agrylin
- Systolic Blood Pressure [ Time Frame: over 1 day ] [ Designated as safety issue: Yes ]Systolic blood pressures in patients with ET receiving Agrylin
- Diastolic Blood Pressure [ Time Frame: over 1 day ] [ Designated as safety issue: Yes ]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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| 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 < 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00413634
Locations
| Spain | |
| Hospitl Del Mar | |
| Barcelona, Spain | |
| Sweden | |
| 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
Shire Development LLC
Investigators
| Principal Investigator: | Carlos Besses Raebel | Spain |
More Information
Additional Information:
No publications provided by Shire Development LLC
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Timothy Whitaker, M.D., Shire |
| ClinicalTrials.gov Identifier: | NCT00413634 History of Changes |
| Other Study ID Numbers: | SPD422-203 |
| Study First Received: | December 19, 2006 |
| Results First Received: | March 5, 2009 |
| Last Updated: | July 20, 2010 |
| 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 |
Additional relevant MeSH terms:
|
Thrombocythemia, Essential Thrombocytosis Blood Coagulation Disorders Hematologic Diseases Blood Platelet Disorders Myeloproliferative Disorders Bone Marrow Diseases Hemorrhagic Disorders Anagrelide |
Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents Therapeutic Uses Hematologic Agents Platelet Aggregation Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013