Hypertension, Pulmonary Clinical Trial
Official title:
Examination of Safety and Effectiveness of IK-3001 (Nitric Oxide for Inhalation) in Japanese Subjects With Pulmonary Hypertension Associated With Cardiac Surgery - Multi-Center, Open-Label, Clinical Study
Sixteen Japanese subjects (6 adults/10 children) with peri- and post-operative pulmonary hypertension associated with cardiac surgery will be evaluated at approx. 6 sites for safety and efficacy of IK-3001.
This is a multi-center, open-label, clinical study of the safety and efficacy of IK-3001 in
16 subjects with peri- and post-operative pulmonary hypertension associated with cardiac
surgery. Two primary sub-sets of this patient population will be evaluated in this study:
1. Adults with severe congestive heart failure having LVAD implant
2. Children requiring surgery for congenital heart disease with corresponding PH or having
Glenn surgery or Fontan surgery for single-ventricle physiology. Children with severe
pulmonary hypertension due to congenital heart disease who require inhaled nitric oxide
(iNO) pre-operatively may also be enrolled.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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