Ignite Creation Date:
2024-05-05 @ 11:40 PM
Last Modification Date:
2024-10-26 @ 10:37 AM
Study NCT ID:
NCT01389271
Status:
COMPLETED
Last Update Posted:
2019-04-25
First Post:
2011-06-27
Brief Title:
Inhaled Iloprost in the Treatment of Patients With Pulmonary Hypertension up to 4 Years
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
Open-label Uncontrolled Prospective Long-term Observation of Inhaled Iloprost in the Treatment of Patients With Pulmonary Hypertension up to 4 Years
Status:
COMPLETED
Status Verified Date:
2019-04
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:
OPTION
Brief Summary:
This is an open-label uncontrolled prospective long-term observation of Specific Drug in the treatment of patients with pulmonary hypertension up to 4 years 160 patients with primary idiopathic and familial pulmonary hypertension PH or pulmonary arterial hypertension PAH due to scleroderma with New York Heart Association NYHA functional class and exercise capacity defined as class III and IV planned to enroll Efficacy safety and tolerability of the drug and the survival of the patients will be observed
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 |
|---|---|---|---|
| VE0910TR | OTHER | Company internal | None |