Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2026-03-02 @ 4:09 PM
Study NCT ID:
NCT01959828
Status:
COMPLETED
Last Update Posted:
2016-09-09
First Post:
2013-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Confirmatory Study of IK-3001 in Japanese Subjects With Peri-/Post-op Pulmonary Hypertension Assoc. With Cardiac Surgery
Sponsor:
Mallinckrodt
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: