Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03904693 | Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed-dose Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH) | PHASE3 | COMPLETED | 187 | — | — | Jul 29, 2019 | Sep 27, 2024 | Dec 19, 2025 | 148 | United States, Australia +17 |
Change in PVR expressed as the ratio of geometric means of EDBT to baseline were reported.
| Arm | Type | Description |
|---|---|---|
| FDC therapy + Placebo macitentan + Placebo tadalafil | EXPERIMENTAL | Subjects to receive FDC macitentan/tadalafil (macitentan 10 mg and tadalafil 40 mg) plus matching placebos for the two other study treatments. |
| Macitentan mono-therapy + Placebo tadalafil + Placebo FDC | ACTIVE_COMPARATOR | Subjects to receive macitentan 10 mg plus matching placebos for the two other study treatments. |
| Tadalafil mono-therapy + Placebo macitentan + Placebo FDC | ACTIVE_COMPARATOR | Subjects to receive tadalafil 40 mg (2 x 20 mg) plus matching placebos for the two other study treatments. |
| Name | Type | Description |
|---|---|---|
| FDC macitentan/tadalafil | DRUG | Film-coated tablet with 10 mg macitentan and 40 mg tadalafil, to be administered orally once daily. |
| Macitentan 10 mg | DRUG | Film-coated tablet with 10 mg macitentan, to be administered orally once daily. |
| Tadalafil 40 mg | DRUG | Film-coated tablet with 40 mg tadalafil (2 x 20 mg tablets), to be administered orally once daily. |
| Placebo FDC | DRUG | Matching placebo not containing any active substance but otherwise identical in appearance to the respective active drug tablet, to be administered orally once daily. |
| Placebo macitentan | DRUG | Matching placebo not containing any active substance but otherwise identical in appearance to the respective active drug tablet, to be administered orally once daily. |
| Placebo tadalafil | DRUG | Matching placebo not containing any active substance but otherwise identical in appearance to the respective active drug tablet, to be administered orally once daily. |
Inclusion Criteria: * Signed and dated informed consent form (ICF) * Confirmed diagnosis of symptomatic PAH in WHO FC II or III * Symptomatic PAH belonging to one of the following subgroups of WHO Group 1 pulmonary hypertension: * Idiopathic * Heritable * Drug- or toxin-induced * Associate...