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: 19 Apr 2018
At a glance
- Drugs Nitric oxide (Primary)
- Indications Pulmonary arterial hypertension
- Focus Adverse reactions; Registrational; Therapeutic Use
- Acronyms INOvation-1
- Sponsors Bellerophon Therapeutics
- 29 Jan 2018 According to a Bellerophon Therapeutics media release, enrollment in this study now exceeds 100 patients, representing more than half of the anticipated enrollment. The Company anticipates the readout of the interim analysis in mid-2018, and the availability of top-line data from the full study toward the end of 2018.
- 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.