Ignite Creation Date:
2024-05-06 @ 8:22 AM
Last Modification Date:
2024-10-26 @ 11:59 AM
Study NCT ID:
NCT02725372
Status:
TERMINATED
Last Update Posted:
2023-02-21
First Post:
2016-01-19
Brief Title:
Clinical Study of Pulsed Inhaled Nitric Oxide Versus Placebo in Symptomatic Subjects With PAH
Sponsor:
Bellerophon Pulse Technologies
Organization:
Bellerophon
Study Overview
Official Title:
A Phase 3 Placebo Controlled Double-Blind Randomized Clinical Study to Determine Efficacy Safety and Tolerability of Pulsed Inhaled Nitric Oxide iNO Versus Placebo in Symptomatic Subjects With PAH Part 1 and Part 2
Status:
TERMINATED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Trial stopped for futility
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INOvation-1
Brief Summary:
Phase 3 placebo controlled double-blind randomized clinical study to determine safety tolerability and efficacy of pulsed inhaled nitric oxide iNO versus placebo in symptomatic subjects with pulmonary arterial hypertension PAH Part 1 and Part 2
Detailed Description:
Phase 3 placebo controlled double-blind randomized clinical study to determine safety tolerability and efficacy of pulsed inhaled nitric oxide iNO versus placebo as add-on therapy in subjects with pulmonary arterial hypertension PAH who remain symptomatic on approved PAH monotherapy or combination approved PAH therapy and long term oxygen therapy LTOT Part 1 and Part 2
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