Second phase III trial of pulsed Inhaled Nitric Oxide (iNO) in treatment of patients with pulmonary arterial hypertension (PAH)

Trial Profile

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Withdrawn prior to enrolment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
  • Most Recent Events

    • 13 Mar 2017 Status changed from planning to withdrawn prior to enrolment, according to a Bellerophon Therapeutics media release.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
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