2026-08-19
minor
Study Status, Arms and Interventions v8
Completion pushed: 2027-09 → 2027-12
Primary completion date2027-09→2027-10
2026-01-08
minor
Study Status, Oversight, IPDSharing v7
Primary completion date2026-09→2027-09
Completion date2026-09→2027-09
2025-07-11
minor
Study Status v6
Re-verified, no change to tracked fields
2025-02-18
minor
Study Status, Oversight, Eligibility, IPDSharing v5
Primary completion date2025-09→2026-09
Eligibility criteria+347 characters
Inclusion Criteria:
Patients ≥ 18 and <8085 years at inclusion,
Dyspnea WHO functional class II to IV,
[...] vernosal fibrosis, Peyronie's disease or history of priapism
Pulmonary or upper respiratory infection requiring antibiotics, or pulmonary embolism in the last 4 weeks before screening
Participation in a respiratory rehabilitation program within the 4 weeks prior to screening or scheduled during the study period
Right heart failure necessitating catecholamine [...]
2024-06-20
minor
Study Status, Eligibility v4
Eligibility criteria+21 characters
Inclusion Criteria:
Patients >≥ 18 and <80 years at inclusion,
Dyspnea WHO functional class [...] nsion defined by :
a mean pulmonary artery pressure (mPAP) >35 mmHg or mPAP ≥25 mmHg with a cardiac index < 2.5 L/min/m²20
associated with normal pulmonary artery wedge pressure (PawP ≤15 mmHg)
and pulmonary vascular resistance (PVR) >35 WU
COPD diagnosed according to current international recomm [...] vital capacity (FVC): FEV1/FVC < 0.70,
Naive patients from PDE5i (sildenafil, tadalafil) PH treatments and who did not receive other specific PH treatmentstreatment in the last 3 months (bosentan, ambrisentan, [...] [...]
Show 3 earlier versions
2024-04-03
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-01→confirmed 2024-02-01
Study sites0→1
2023-12-12
minor
Study Status v2
Start date2023-09→2024-01
2023-05-25
minor
Study Status, Arms and Interventions v1
InterventionsTadalafil (Drug)→Placebo (Drug), Tadalafil (Drug)
2023-04-25
minor
Original filing