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Tadalafil for Severe Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease

Study acronym: ERASE PH-COPD
StatusRecruiting
PhasePhase 3
Started2024-02-01
View on ClinicalTrials.gov ↗

Amendment history

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
ERASE PH-COPD is a randomized double-blind study, with 2 parallel groups. Patients with severe pulmonary hypertension due to chronic obstructive pulmonary disease, will be randomly assigned to receive Tadalafil orally or placebo.
Trial Details
NCT Number NCT05844462
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Conditions Pulmonary Hypertension, Chronic Obstructive Pulmonary Disease
Enrollment 200 participants
Start Date 2024-02-01
Primary Completion 2027-10 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-08-20