An Open-Label Long-Term Safety Study of Inhaled Nitric Oxide (iNO) for Pulmonary Arterial Hypertension (PAH)
An open-label, long-term study to evaluate the safety of inhaled nitric oxide (iNO) in subjects with pulmonary arterial hypertension (PAH) who participated in IK-7001-PAH-201 and PULSE-PAH-004 to provide these patients with continued access to chronic iNO until the time of approval or development of iNO in PAH is discontinued.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
University of Alabama at Birmingham
Birmingham, Alabama, United States
West Los Angeles VA Healthcare Center
Los Angeles, California, United States
Incidence of Serious Adverse Events
Incidence of Serious Adverse Events from baseline to end of study
Time frame: Through Study Completion, anticipated 3 years
Incidence of INOpulse device malfunction and/or device failure leading to an AE
Incidence of INOpulse device malfunction and/or device failure leading to an AE from baseline to end of study
Time frame: Through Study Completion, anticipated 3 years
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University of Colorado Denver
Aurora, Colorado, United States
Cleveland Clinic Florida
Weston, Florida, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Mount Sinai Beth Israel
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
UC Health University of Cincinnati
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Ohio State University, Wexner Medical Center
Columbus, Ohio, United States
...and 7 more locations