NCT01959828

Confirmatory Study of IK-3001 in Japanese Subjects With Peri-/Post-op Pulmonary Hypertension Assoc. With Cardiac Surgery

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Mallinckrodt · Industry
• Sex: All
• Age: 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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: 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.

Conditions

• Hypertension, Pulmonary
• Ventricular Dysfunction, Left

Interventions

Type	Name	Description
DRUG	IK-3001

Timeline

• Start date: 2013-09-01
• Primary completion: 2014-03-01
• Completion: 2014-07-01
• First posted: 2013-10-10
• Last updated: 2016-09-09

Locations

7 sites across 1 country: Japan