Ensayos clínicos

Inclusion Criteria:

• Signed and dated informed consent form.
• Male and female subjects from 18 to 85 years old (inclusive).
• With established diagnosis of inoperable CTEPH (i.e., technically non-operable) or persistent/recurrent CTEPH after pulmonary endarterectomy (PEA) and/or balloon pulmonary angioplasty (BPA), as confirmed by the corresponding adjudication committee.
• With pulmonary hypertension (PH) in WHO FC I-IV.
• Subject able to perform the 6-minute walk test (6MWT) with a minimum distance of 100 m and a maximum distance of 450 m at screening visit.
• Women of childbearing potential must have a negative pregnancy test at screening and randomization and must agree to undertake monthly urine pregnancy tests, and to use a reliable method of birth control from screening visit up to at least 30 days after study treatment discontinuation. If a hormonal contraceptive is chosen it must be taken for at least 1 month prior to randomization.

Exclusion Criteria:

• Planned or current treatment with another investigational treatment up to 3 months prior to randomization.
• Any co-morbid condition that may influence the ability to perform a reliable and reproducible 6MWT, including use of walking aids (cane, walker, etc.).  If a patient uses a walking aid from time to time but does not have any co-morbid condition, and is able to perform a reliable and reproducible 6MWT on their own (i.e., without any walking aids), then they can be included.
• Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation.
• Known concomitant life-threatening disease with a life expectancy <12 months.