Pulmonary Arterial Hypertension Clinical Trial
Official title:
A Multiple Ascending Dose Study of Tadalafil to Assess the Pharmacokinetics and Safety in a Pediatric Population With Pulmonary Arterial Hypertension
The purpose of this study is to see how much study drug is in the blood of children with pulmonary arterial hypertension (PAH) after dosing to establish the correct dose for further clinical research.
During Period I, tadalafil will be administered orally, once daily, at a low dose for approximately 5 weeks followed by a high dose for approximately 5 weeks. Dose levels are calculated based on body weight cohorts. Heavy weight cohort >=40 kg, middle weight cohort >=25 kg to <40 kg. Light weight cohort<25 kg. Participants who complete Period 1 may continue taking tadalafil in Period 2 for at least 2 years. Starting dose will not exceed the maximum weight range dose established in Period 1 and after the first 3 months of Period 2, the dose may be adjusted based on available safety and efficacy information. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04076241 -
Effects of Adding Yoga Respiratory Training to Osteopathic Manipulative Treatment in Pulmonary Arterial Hypertension
|
N/A | |
Completed |
NCT05521113 -
Home-based Pulmonary Rehabilitation With Remote Monitoring in Pulmonary Arterial Hypertension
|
||
Recruiting |
NCT04972656 -
Treatment With Ambrisentan in Patients With Borderline Pulmonary Arterial Hypertension
|
N/A | |
Completed |
NCT04908397 -
Carnitine Consumption and Augmentation in Pulmonary Arterial Hypertension
|
Phase 1 | |
Active, not recruiting |
NCT03288025 -
Pulmonary Arterial Hypertension Improvement With Nutrition and Exercise (PHINE)
|
N/A | |
Completed |
NCT01959815 -
Novel Screening Strategies for Scleroderma PAH
|
||
Recruiting |
NCT04266197 -
Vardenafil Inhaled for Pulmonary Arterial Hypertension PRN Phase 2B Study
|
Phase 2 | |
Active, not recruiting |
NCT06092424 -
High Altitude (HA) Residents With Pulmonary Vascular Diseseases (PVD), Pulmonary Artery Pressure (PAP) Assessed at HA (2840m) vs Sea Level (LA)
|
N/A | |
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 | |
Terminated |
NCT02060487 -
Effects of Oral Sildenafil on Mortality in Adults With PAH
|
Phase 4 | |
Terminated |
NCT02253394 -
The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study
|
Phase 4 | |
Withdrawn |
NCT02958358 -
FDG Uptake and Lung Blood Flow in PAH Before and After Treatment With Ambrisentan
|
N/A | |
Terminated |
NCT01953965 -
Look at Way the Heart Functions in People With Pulmonary Hypertension (PH) Who Have Near Normal Right Ventricle (RV) Function and People With Pulmonary Hypertension Who Have Impaired RV Function. Using Imaging Studies PET Scan and Cardiac MRI.
|
Phase 2 | |
Unknown status |
NCT01712997 -
Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Hypertension Patients
|
Phase 3 | |
Withdrawn |
NCT01723371 -
Beta Blockers for Treatment of Pulmonary Arterial Hypertension in Children
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT01649739 -
Vardenafil as add-on Therapy for Patients With Pulmonary Hypertension Treated With Inhaled Iloprost
|
Phase 4 | |
Completed |
NCT01548950 -
Drug Therapy and Surgery in Congenital Heart Disease With Pulmonary Hypertension
|
N/A | |
Completed |
NCT01165047 -
Nitric Oxide, GeNO Nitrosyl Delivery System
|
Phase 2 | |
Completed |
NCT00942708 -
Safety and Efficacy of Fluoxetine in Pulmonary Arterial Hypertension
|
Phase 2 | |
Completed |
NCT00963001 -
Effect of Food on the Pharmacokinetics of Oral Treprostinil
|
Phase 1 |