Ignite Creation Date:
2024-05-05 @ 11:56 PM
Last Modification Date:
2024-10-26 @ 10:42 AM
Study NCT ID:
NCT01457781
Status:
COMPLETED
Last Update Posted:
2023-02-27
First Post:
2011-10-12
Brief Title:
Inhaled Nitric OxideINOpulse DS for Pulmonary Arterial Hypertension PAH
Sponsor:
Bellerophon Pulse Technologies
Organization:
Bellerophon
Study Overview
Official Title:
A Phase 2 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 Symptomatic Subjects With Pulmonary Arterial Hypertension PAH
Status:
COMPLETED
Status Verified Date:
2022-07
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:
PAH
Brief Summary:
This is a Phase 2 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 Symptomatic Subjects with Pulmonary Arterial Hypertension PAH
Detailed Description:
Study to determine if inhaled nitric oxide iNO given through a special delivery device INOpulse DS is safe and efficacious in treating Pulmonary Arterial Hypertension PAH Medical literature and clinical experience suggests that iNO at pulsed doses of 0013 to 01 mgkg per hour for 1 month to 2 years appears safe and suggests efficacy for the treatment of pulmonary hypertension
There are two parts to this study In Part 1 week 0 to week 16 the objectives are to determine the safety tolerability efficacy and exploratory objectives of two different doses of iNO delivered by a pulsed delivery device in symptomatic subjects with PAH who remain symptomatic due to PAH on approved PAH monotherapy or combination approved PAH therapy In Part 2 week 17 to end of study Part 2 EOS Part 2 the objective is to compile data on the long-term effects of iNO on safety tolerability clinical and hemodynamic measures
There are two parts to this study In Part 1 week 0 to week 16 the objectives are to determine the safety tolerability efficacy and exploratory objectives of two different doses of iNO delivered by a pulsed delivery device in symptomatic subjects with PAH who remain symptomatic due to PAH on approved PAH monotherapy or combination approved PAH therapy In Part 2 week 17 to end of study Part 2 EOS Part 2 the objective is to compile data on the long-term effects of iNO on safety tolerability clinical and hemodynamic measures
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