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
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04095286 -
Relative Bioavailability Study of Marketed and Lower Dose Ambrisentan in Healthy Adult Participants
|
Phase 1 | |
| Enrolling by invitation |
NCT03683186 -
A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension
|
Phase 3 | |
| Completed |
NCT02191137 -
Measuring Outcomes In Patients With Pulmonary Arterial Hypertension Not on Active Treatment (MOTION)
|
Phase 4 | |
| Withdrawn |
NCT01202045 -
Stress Echocardiography in the Detection of Pulmonary Arterial Hypertension in Systemic Sclerosis Patients
|
N/A | |
| Completed |
NCT00963027 -
Effect of Esomeprazole on the Pharmacokinetics of Oral Treprostinil
|
Phase 1 | |
| Completed |
NCT01121458 -
Clevidipine for Vasoreactivity Evaluation of the Pulmonary Arterial Bed
|
Phase 4 | |
| Completed |
NCT00963001 -
Effect of Food on the Pharmacokinetics of Oral Treprostinil
|
Phase 1 | |
| Terminated |
NCT00825266 -
Insulin Resistance in Pulmonary Arterial Hypertension
|
Phase 4 | |
| Terminated |
NCT00384865 -
A Study of Aspirin and Simvastatin in Pulmonary Arterial Hypertension
|
Phase 2 | |
| Active, not recruiting |
NCT03926572 -
Acute Decompensation of Pulmonary Hypertension
|
N/A | |
| Completed |
NCT02826252 -
Examination of Ventavis (Iloprost) Inhalation Behavior Using the I-Neb AAD System in Patients With Pulmonary Arterial Hypertension When Switching the Iloprost Nebulizer Solution for Inhalation From 10 μg/mL (V10) to 20 μg/mL (V20)
|
N/A | |
| Completed |
NCT02545465 -
A Study to Understand the Treatment Patterns in Patients With Pulmonary Arterial Hypertension or Chronic Thromboembolic Pulmonary Hypertension During a Switch of Treatment to Adempas in Real-life Clinical Practice
|
N/A | |
| Recruiting |
NCT04498299 -
Stress Echocardiography in Patients Recovery From Mild COVID-19 Illness
|
||
| Recruiting |
NCT02558582 -
Effect of Exercise Training in Patients With Pulmonary Hypertension
|
N/A | |
| Active, not recruiting |
NCT02562235 -
Riociguat in Children With Pulmonary Arterial Hypertension (PAH)
|
Phase 3 | |
| Completed |
NCT02755298 -
Chronic Clinical Effect of Acetazolamide
|
Phase 2/Phase 3 | |
| Completed |
NCT02576002 -
Epidemiology and Treatment Patterns of Paediatric PAH (Pulmonary Arterial Hypertension)
|
N/A | |
| Terminated |
NCT03043976 -
Using Step Count to Enhance Daily Physical Activity in Pulmonary Hypertension
|
N/A | |
| Completed |
NCT01178073 -
A Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)
|
Phase 3 | |
| Completed |
NCT01317134 -
Endothelial Function in Patients With Pulmonary Arterial Hypertension
|
N/A |