Initial Dual Oral Combination Therapy Versus Standard-of-care Initial Oral Monotherapy Prior to Balloon Pulmonary Angioplasty in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension

Summary

Participation Requirements

Description

The Screening period will last up 28 days maximum. It begins at the first screening assessment and ends with subject inclusion. The Screening visit date is the date when the first screening assessment is performed. The Treatment period will start at Day 1 with the first dose of riociguat and ends at...

The Screening period will last up 28 days maximum. It begins at the first screening assessment and ends with subject inclusion. The Screening visit date is the date when the first screening assessment is performed. The Treatment period will start at Day 1 with the first dose of riociguat and ends at Week 42 / End-of-Treatment (EOT) visit. On Day 8, the experimental treatment with macitentan / placebo will be started. During this period, regular hospital visits will be performed (Week 16, Week 29). In addition, laboratory tests will be performed every 4 weeks as part of standard of care. Subjects who are still symptomatic (WHO FC II to IV) and have PVR? 240 dyn.sec.cm-5 at week 16 will be offered additional treatment by BPA. Safety follow-up period: After study drug discontinuation, all subjects will enter a Safety follow-up period which ends with safety follow up visit/end of study, 30-35 days after the last intake to the study drug. All subjects who prematurely and definitively discontinue study drug before Week 42 must have a premature EOT visit as soon as possible but no later than 7 days after the decision of definitive discontinuation of study drug and have a safety follow-up visit as described above. Post-Treatment Observational Period: Subjects are to remain in the study after premature EOT and safety visit and undergo all study assessments up to Week 42, except subjects discontinuing study drug due to PH-related disease progression who will have a premature EOT visit and Safety follow-up visit and will be withdrawn from the study. A total of 96 newly diagnosed and treatment-naïve subjects with inoperable CTEPH will be randomly assigned in a 1:1 ratio to receive either macitentan (n=48) or placebo (n=48) combined with standard of care with riociguat.

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