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 Pulmonary Arterial Hypertension (PAH) (Part 1 and Part 2)

Trial Profile

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 Pulmonary Arterial Hypertension (PAH) (Part 1 and Part 2)

Recruiting
Phase of Trial: Phase III

Latest Information Update: 07 Aug 2017

At a glance

  • Drugs Nitric oxide (Primary)
  • Indications Pulmonary arterial hypertension
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms INOvation-1
  • Sponsors Bellerophon Therapeutics
  • Most Recent Events

    • 07 Aug 2017 According to a Bellerophon Therapeutics media release, An interim read-out of the trial is planned when 16-week data is available on approximately 75 subjects. Both the interim analysis as well as top line results for the study are expected to be reported in 2018.
    • 07 Aug 2017 According to a Bellerophon Therapeutics media release, till now 100 sites have been initiated in 16 countries with around 50 patients already randomized.
    • 14 Jul 2017 According to European Clinical Trials Database record, primary endpoint has been added into the study hence trial focus has also changed.
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