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)

NCT03602781 Phase 3 WITHDRAWN

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

Details

Lead sponsor	Bellerophon Pulse Technologies
Phase	Phase 3
Status	WITHDRAWN
Start date	2018-08
Completion	2020-06

Conditions

• Pulmonary Arterial Hypertension

Interventions

• Placebo
• iNO

Primary outcomes

• Time to clinical worsening during iNO withdrawal for up to 8 weeks — 8 weeks
  A clinical worsening event is defined as: 1. Death (all-cause mortality) 2. Atrial septostomy 3. Hospitalization due to worsening of PAH 4. Need to start additional specific PAH treatment 5. Decrease of \>15% in 6 Minute Walk Distance from randomization into the study 6. Worsening of WHO Functional Class (e.g., from Class II to Class III or IV, OR Class III to Class IV)

Countries

United States, Canada