Pulmonary Arterial Hypertension Clinical Trial
Official title:
An Open-label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH
This study is being conducted to assess the long-term safety, tolerability, and efficacy of sotatercept (MK-7962, formerly called ACE-011) in participants with Pulmonary Arterial Hypertension (PAH). This open-label, long-term follow-up (LTFU) study is supported by data from the PULSAR study (Phase 2, NCT03496207) in which treatment with sotatercept resulted in hemodynamic and functional improvements in the study participants, including those receiving maximal PAH therapy with double/triple drug combinations and intravenous prostacyclin. The primary objective of this open-label, LTFU study is to evaluate the long-term safety and tolerability of sotatercept when added to background PAH therapy in adult participants with PAH who have completed prior sotatercept studies. The secondary objective is to evaluate continued efficacy in adult participants with PAH who have completed prior sotatercept studies.
Participants eligible to enroll in the study will have participated in and completed the relevant study requirements of the parent PAH sotatercept clinical studies. ;
| 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 | |
| Not yet recruiting |
NCT01649739 -
Vardenafil as add-on Therapy for Patients With Pulmonary Hypertension Treated With Inhaled Iloprost
|
Phase 4 | |
| 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 | |
| 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 |