Ignite Creation Date:
2024-05-06 @ 1:47 AM
Last Modification Date:
2024-10-26 @ 11:09 AM
Study NCT ID:
NCT01894035
Status:
COMPLETED
Last Update Posted:
2018-04-09
First Post:
2013-07-03
Brief Title:
Non-interventional Multi-center Study on Patients Under Routine Treatment of Pulmonary Arterial Hypertension PAH With Inhaled Iloprost Using I-Neb as a Device for Inhalation
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
Study to Assess the Compliance of Patients With Pulmonary Arterial Hypertension Treated With Inhaled Iloprost
Status:
COMPLETED
Status Verified Date:
2018-03
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:
COMPHI
Brief Summary:
This pilot non-interventional company-sponsored multi-center study documents observational data on patients under routine treatment of Pulmonary Arterial Hypertension PAH with inhaled iloprost using I-Neb device for the inhalation
The planned study recruitment time is 18 months The maximum follow up period in this study will be 12 months
The data will be collected from patients who have initiated the treatment mentioned above inhaled iloprost using I-Neb device since February 1st 2013
Frequency of visits and procedures will be performed under routine conditions The primary objective of this study is to assess the compliance of patients with WHONYHA World Health OrganizationNew York Heart Association functional Class III Pulmonary Arterial Hypertension treated with Inhaled Iloprost in clinical practice using the I-neb Insight tool
The planned study recruitment time is 18 months The maximum follow up period in this study will be 12 months
The data will be collected from patients who have initiated the treatment mentioned above inhaled iloprost using I-Neb device since February 1st 2013
Frequency of visits and procedures will be performed under routine conditions The primary objective of this study is to assess the compliance of patients with WHONYHA World Health OrganizationNew York Heart Association functional Class III Pulmonary Arterial Hypertension treated with Inhaled Iloprost in clinical practice using the I-neb Insight tool
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 |
|---|---|---|---|
| VE1310PT | OTHER | Company internal | None |