Tadalafil for Severe Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-85
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients ≥ 18 and <85 years at inclusion,
Dyspnea WHO functional class II to IV,
a mean pulmonary artery pressure (mPAP) >20
associated with normal pulmonary artery wedge pressure (PawP ≤15 mmHg)
Disqualifiers
Patients with a medical disorder, condition, or history of such that would impair the patient's ability to participate or complete this study in the opinion of the investigator,
Patients with underlying medical disorders and anticipated life expectancy below 12 months (eg active cancer disease with localized and/or metastasized tumor mass),
PH not due to chronic respiratory diseases (group 1, 2, 4 or 5 of the clinical classification of PH),
Other respiratory diseases: interstitial lung disease, sarcoidosis, lymphangioleiomyomatosis, histiocytosis, or untreated severe sleep apnea disorders,
Trial design
Design model
Parallel
Treatments tested in this trial
Tadalafil
DrugOral Tadalafil
Placebo
DrugOral Placebo
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Experimental armExperimental treatment 1 intervention
Group B: Control armPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
6 minute Walk
The distance cover in meter during a 6-minute walk at week 16 post-randomization for patients treated with tadalafil compared to placebo
Time frame
16 weeksSponsors and contacts
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Source ClinicalTrials.gov