2 completed, 2 terminated. 4 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 4 | Completed 2, Terminated 2 |
Follow Eisenmenger Complex: new trials by email Literature Review of Eisenmenger Complex trials Research Report on Eisenmenger Complex
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Clinical Study to Assess the Long-term Safety, Tolerability, and Efficacy of Macitentan in Subjects With Eisenmenger Syndrome Macitentan 10 mg tablet, once daily. - Pulmonary Arterial Hypertension | Phase 3 | Terminated | Actelion | 217 | 2013-09-10 | 2019-04-16 |
| Clinical Study to Evaluate the Effects of Macitentan on Exercise Capacity in Subjects With Eisenmenger Syndrome Macitentan 10 mg, Placebo - Pulmonary Arterial Hypertension | Phase 3 | Completed | Actelion | 226 | 2013-05-21 | 2018-02-23 |
| Therapy of Pulmonary Arterial Hypertension (PAH) - Treatment With Sildenafil in Eisenmenger Patients Sildenafil, Placebo - Pulmonary Arterial Hypertension (PAH) | Phase 3 | Terminated | Competence Network for Congenital Heart Defects | 24 | 2007-12-01 | 2012-06-06 |
| Combination Treatment With Bosentan and Sildenafil to Patients With Eisenmengers Syndrome Bosentan and Sildenafil - Eisenmenger Syndrome | Phase 3 | Completed | Copenhagen University Hospital, Rigshospitalet | 20 | 2006-03-01 | 2008-01-24 |
Pulmonary Arterial Hypertension (3) · Hypertension (1)
Cardiovascular Abnormalities (4) · Cardiovascular Diseases (4) · Congenital Abnormalities (4) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (4) · Heart Defects, Congenital (4) · Heart Diseases (4) · Hypertension, Pulmonary (3) · Lung Diseases (3) · Respiratory Tract Diseases (3) · Vascular Diseases (1)
Sildenafil Citrate (2) · macitentan (2) · Bosentan (1) · Tablets (1)
Actelion (2) · Competence Network for Congenital Heart Defects (1) · Copenhagen University Hospital, Rigshospitalet (1)
Germany (3) · Austria (2) · Bulgaria (2) · Chile (2) · China (2) · France (2) · Greece (2) · Malaysia (2) · Mexico (2) · Philippines (2) · Poland (2) · Portugal (2) · Romania (2) · Russia (2) · Serbia (2)
Ingram Schulze-Neick, MD (1) · Lars Soendergaard, MD (1) · Siegrun Mebus, MD (1)