drugset / Trial / NCT01959828
Confirmatory Study of IK-3001 in Japanese Subjects With Peri-/Post-op Pulmonary Hypertension Assoc. With Cardiac Surgery
NaSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2013-09
- Primary completion
- 2014-03
- Completion
- 2014-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nitric Oxide | Other / unclassified | 10 ppm | Inhaled |
| Subject | Nitric Oxide | Other / unclassified | 20 ppm | Inhaled |
| Subject | Nitric Oxide | Other / unclassified | 40 ppm | Inhaled |