NCT03602781

Study of PAH Subjects With LTOT Use That Have Demonstrated Improved Exercise Tolerance With the Use of Inhaled Nitric

Phase 3, Multicenter, Randomized, Double-blind, Placebo Controlled Withdrawal Study of Pulmonary Arterial Hypertension(PAH) Subjects With LTOT Use That Have Demonstrated Improved Exercise Tolerance With the Use of Inhaled Nitric Oxide (INO)

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Bellerophon Pulse Technologies · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study of PAH Subjects with LTOT Use that have Demonstrated Improved Exercise Tolerance with the use of Inhaled Nitric Oxide

Detailed description

Phase 3, Multicenter, Randomized, Double-blind, Placebo Controlled Withdrawal Study of Pulmonary Arterial Hypertension(PAH) Subjects with LTOT Use that have Demonstrated Improved Exercise Tolerance with the use of Inhaled Nitric Oxide (INO)

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	Placebo	Placebo at a dose setting of 75 mcg/kg IBW/hr
DRUG	iNO	iNO at a dose setting of 75 mcg/kg IBW/hr

Timeline

• Start date: 2018-08-01
• Primary completion: 2019-06-01
• Completion: 2020-06-01
• First posted: 2018-07-27
• Last updated: 2023-02-21

Locations

4 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study