Study of PAH Subjects with LTOT Use that have Demonstrated Improved Exercise Tolerance with the use of Inhaled Nitric Oxide
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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Bluhm Cardiovascular Institute, Clinical Trials Unit
Chicago, Illinois, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Peter Lougheed Centre
Calgary, Alberta, Canada
Toronto General Hospital, University Health Network
Toronto, Ontario, Canada
Time to clinical worsening during iNO withdrawal for up to 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)
Time frame: 8 weeks
Difference in clinical worsening events that occur during iNO withdrawal for up to 8 weeks between those treated with iNO ≥ 10 months prior to the start of withdrawal of iNO vs. those treated < 10 months prior to initiation of withdrawal to iNO.
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)
Time frame: 8 weeks
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