Trials / Terminated
TerminatedNCT02725372
Clinical Study of Pulsed, Inhaled Nitric Oxide Versus Placebo in Symptomatic Subjects With PAH
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 PAH (Part 1 and Part 2)
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 207 (actual)
- Sponsor
- Bellerophon Pulse Technologies · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
Phase 3, placebo controlled, double-blind, randomized clinical study to determine safety, tolerability, and efficacy of pulsed, inhaled nitric oxide (iNO) versus placebo in symptomatic subjects with pulmonary arterial hypertension (PAH). Part 1 and Part 2
Detailed description
Phase 3, placebo controlled, double-blind, randomized, clinical study to determine safety, tolerability and efficacy of pulsed inhaled nitric oxide (iNO) versus placebo as add-on therapy in subjects with pulmonary arterial hypertension (PAH) who remain symptomatic on approved PAH monotherapy or combination approved PAH therapy and long term oxygen therapy (LTOT). (Part 1 and Part 2)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Inhaled Nitric Oxide 75 mcg/kg IBW/hr | Inhaled Nitric Oxide 15mcg/Kg IBW/hr for two week run in period dose titrated to Inhaled Nitric Oxide 75 mcg/kg IBW/hr at randomizationTreatment Period (Week 3 to Week 18) |
| DRUG | Placebo | Part 1 Placebo arm: Inhaled Nitric Oxide 15mcg/Kg IBW/hrfor two week run in period dose titrated to Inhaled Nitric Oxide 75 mcg/kg IBW/hr at randomizationTreatment Period |
Timeline
- Start date
- 2016-04-01
- Primary completion
- 2018-08-01
- Completion
- 2018-08-01
- First posted
- 2016-04-01
- Last updated
- 2023-02-21
- Results posted
- 2023-01-25
Locations
109 sites across 18 countries: United States, Australia, Austria, Belgium, Canada, Colombia, Croatia, Czechia, France, Germany, Israel, Italy, Netherlands, Portugal, Serbia, Spain, Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT02725372. Inclusion in this directory is not an endorsement.