Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00478569
Status:
COMPLETED
Last Update Posted:
2014-05-28
First Post:
2007-05-23
Brief Title:
Adherence to PTH1-84 Treatment FP-002-IM
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
Adherence to PTH1-84 Treatment in Europe A Non-interventional Cohort Study Collecting Safety Information and Examining Reasons and Predictors for Adherence to PTH1-84 Treatment in Usual Clinical Settings
Status:
COMPLETED
Status Verified Date:
2014-04
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:
The primary objective is
1 to describe adherence and the main factors influencing adherence to PTH1-84 treatment when prescribed in a normal clinical setting
The secondary objectives are
1 to describe the demographics and clinical characteristics of the patients that in a normal clinical setting are started on a treatment regimen with PTH1-84
2 to describe using available data the long term treatment effectiveness during the 24 months following initiation of PTH1-84 treatment in a normal clinical setting
3 to monitor safety for 24 months following initiation of PTH1-84 treatment in a patient in a normal clinical setting
1 to describe adherence and the main factors influencing adherence to PTH1-84 treatment when prescribed in a normal clinical setting
The secondary objectives are
1 to describe the demographics and clinical characteristics of the patients that in a normal clinical setting are started on a treatment regimen with PTH1-84
2 to describe using available data the long term treatment effectiveness during the 24 months following initiation of PTH1-84 treatment in a normal clinical setting
3 to monitor safety for 24 months following initiation of PTH1-84 treatment in a patient in a normal clinical setting
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