Ignite Creation Date:
2024-05-05 @ 11:59 PM
Last Modification Date:
2024-10-26 @ 10:43 AM
Study NCT ID:
NCT01469169
Status:
COMPLETED
Last Update Posted:
2017-12-07
First Post:
2011-11-08
Brief Title:
Inhaled Iloprost Ventavis Efficacy Safety and Pharmacokinetics PK Confirmation Study
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
A Multi-center Non-randomized Open Label Single-arm Study to Evaluate the Efficacy Safety and Pharmacokinetics PK of BAY q 6256 Iloprost Inhalation in Patients With Pulmonary Arterial Hypertension PAH
Status:
COMPLETED
Status Verified Date:
2017-12
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:
IBUKI
Brief Summary:
This study is to investigate the efficacy safety and Pharmacokinetics PK of Inhaled Iloprost Ventavis therapy in Japanese pulmonary arterial hypertension PAH patients in Main Treatment Phase 12 weeks and to investigate the safety tolerability and efficacy of longterm Inhaled Iloprost Ventavis therapy in Japanese PAH patients in Extension Phase
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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