Ignite Creation Date:
2024-05-06 @ 7:35 AM
Last Modification Date:
2024-10-26 @ 11:50 AM
Study NCT ID:
NCT02562235
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2015-09-28
Brief Title:
Riociguat in Children With Pulmonary Arterial Hypertension PAH
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
Open-label Individual Dose Titration Study to Evaluate Safety Tolerability and Pharmacokinetics of Riociguat in Children From 6 to Less Than 18 Years of Age With Pulmonary Arterial Hypertension PAH
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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:
PATENT-CHILD
Brief Summary:
This study was designed to evaluate the safety tolerability pharmacodynamics and pharmacokinetics of riociguat at age- sex- and body-weight-adjusted doses of 05 mg 10 mg 15 mg 20 mg and 25 mg TID in children from 6 to less than 18 years with pulmonary arterial hypertension PAH group 1 The study design consisted of a main study part followed by an optional long-term extension part The main treatment period consisted of two phases titration phase up to 8 weeks and a maintenance phase up to 16 weeks
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 2014-003952-29 | EUDRACT_NUMBER | None | None |