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About
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.
Full description
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:
Enrollment
Sex
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Volunteers
Inclusion criteria
Subjects must meet one of the following criteria:
For women of childbearing potential, a negative result for a pregnancy test documented prior to enrollment.
Subjects must give written informed consent. If the subject is a minor the subject's legally acceptable representative (parent or legal guardian) must give written informed consent.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
18 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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