Health Condition 1: I10- Essential (primary) hypertension
Conditions
Interventions
Intervention1: Selexipag: oral tablets containing 200 μg of selexipag. Depending on the iMTD, subjects will receive 1 to 8 tablets at each administration
Control Intervention1: Placebo: Oral tablets
Sponsors
Johnson Johnson Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: -Signed and dated informed consent form - 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 Iâ??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
Exclusion criteria: -Planned or current treatment with another investigational treatment up to 3 months prior to randomization. - Any known factor or disease that might interfere with treatment compliance, study conduct, or interpretation of the results, such as drug or alcohol dependence or psychiatric disease. - Known concomitant life-threatening disease with a life expectancy - Planned balloon pulmonary angioplasty within 26 weeks after randomization. - Change in dose or initiation of new PH-specific therapy within 90 days prior to the baseline RHC (and LHC, if needed) qualifying for enrollment for the hemodynamic cohort and within 90 days prior to randomization (Visit 2) for the non-hemodynamic cohort - Treatment with prostacyclin (epoprostenol), prostacyclin analogs (i.e., treprostinil, iloprost, beraprost) or prostacyclin receptor agonists (i.e., selexipag) within 90 days prior to randomization (visit 2) except those given at vasodilator testing during RHC - Change in dose or initiation of new diuretics and/or calcium channel blockers within 1 week prior to baseline RHC (and LHC, if needed) - Any co-morbid condition that may influence the ability to perform a reliable and reproducible 6MWT, including use of walking aids (cane, walker, etc). - Any other criteria as per selexipag Summary of Product Characteristics (SmPC). - Exclusion criteria related to comorbidities: severe coronary heart disease or unstable angina as assessed by the investigator; mocardial infarction within the last 6 months prior to or during Screening; decompensated cardiac failure if not under close supervision; severe arrhythmias as assessed by the investigator; cerebrovascular events (example transient ischemic attack, stroke) within the last 3 months prior to or during screening; congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension. (PH); known or suspicion of pulmonary veno-occlusive disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent of baseline Pulmonary vascular resistance (PVR) at Week 20Timepoint: Percent of baseline Pulmonary vascular resistance (PVR) at Week 20 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) World Health Organization Functional Class (WHO FC) improvement at Week 26. 2) Change from baseline to Week 26 in Pulmonary arterial hypertension-symptoms and impact questionnaire (PAH-SYMPACT)Cardiopulmonary and Cardiovascular Symptom Domains 3) Change from Baseline to Week 26 in Borg Dyspnea index or Borg CR10 Scale 4) Change from baseline to Week 26 in N-terminal pro b-type natriuretic peptide (NT pro-BNP)Timepoint: Week 26;All-Cause Death or Hospitalizations Related to PH WorseningTimepoint: Up to end of DB treatment visit (maximum 59 months);Change from baseline to Week 26 in 6-minute walk distance (6MWD)Timepoint: Week 26;Time to clinical worseningTimepoint: From baseline up to end of DB treatment visit (maximum 59 months) | — |
Countries
Argentina, Australia, Austria, Brazil, Bulgaria, Canada, China, Czech Republic, Denmark, Germany, Hungary, India, Ireland, Israel, Italy, Mexico, Poland, Republic of Korea, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States of America
Contacts
Public ContactDr Sanish Davis
Johnson & Johnson Private Limited
Outcome results
None listed