Second phase III trial of pulsed Inhaled Nitric Oxide (iNO) in treatment of patients with pulmonary arterial hypertension (PAH)
Withdrawn prior to enrolment
Phase of Trial: Phase III
Latest Information Update: 13 Mar 2017
At a glance
- Drugs Nitric oxide (Primary)
- Indications Pulmonary arterial hypertension
- Focus Therapeutic Use
- Acronyms INOvation-2
- 13 Mar 2017 Status changed from planning to withdrawn prior to enrolment, according to a Bellerophon Therapeutics media release. This study has been replaced with a randomized withdrawal study (profile 280452) that will recruit approximately 40 patients from INOvation-1 study.
- 04 Jan 2017 According to a Bellerophon Therapeutics media release, company has received confirmation from the USFDA for acceptance of modifications to its Phase 3 program for INOpulse in Pulmonary Arterial Hypertension (PAH). Under the newly modified Phase 3 program, INOvation-1 and other confirmatory trial (see profile 280452, replacing the INOvation-2 study) will support a New Drug Application filing for INOpulse in PAH subjects on long term oxygen treatment (LTOT).
- 04 Jan 2017 Planned number of patients changed from 270 to 282, as reported in a Bellerophon Therapeutics media release