Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00413634
Status:
COMPLETED
Last Update Posted:
2021-06-29
First Post:
2006-12-19
Brief Title:
The Pharmacokinetics of Anagrelide in Elderly and Young Patients With Essential Thrombocythaemia ET
Sponsor:
Shire
Organization:
Takeda
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Age related differences in response to a drug could arise from variation in pharmacokinetic PK andor 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2004-004058-20 | EUDRACT_NUMBER | None | None |