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)
Phase of Trial: Phase III
Latest Information Update: 14 Sep 2017
At a glance
- Drugs Nitric oxide (Primary)
- Indications Pulmonary arterial hypertension
- Focus Adverse reactions; Registrational; Therapeutic Use
- Acronyms INOvation-1
- Sponsors Bellerophon Therapeutics
- 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.