pulmonary arterial hypertension
Conditions
Interventions
Switch from Flolan to ACT-385781A and continue the medication of ACT-385781A by the end of study.
Sponsors
National Cerebral and Cardiovascular Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female aged 20 years and above 2. Patients with the following types of pulmonary arterial hypertension (PAH) belonging to WHO Group I: _ Idiopathic (IPAH) _ Heritable (HPAH) _ Associated (APAH) with Drugs and toxins _ Associated (APAH) with Connective tissue diseases 3. Patients treated with Flolan for at least 3 months and on a stable dose for at least 30 day prior to enrollment 4. Females who are lactating or pregnant (positive pre-treatment pregnancy tests) or females who are not using a reliable method of birth control during the study and for at least one month after last administration of study drug 5. Signed informed consent prior to initiation of any study mandated procedure
Exclusion criteria
Exclusion criteria: 1. Patients with respiratory and/or cardiovascular distress in need of emergency care 2. Known or suspicion of pulmonary veno-occlusive disease (PVOD) 3. Current use of IV inotropic agents 4. Current use of any prostacyclin or prostacyclin analog other than Flolan. 5. Tachycardia with heart rate > 120 beats/min at rest 6. Known hypersensitivity to the formulations ACT-385781A or any of its excipients, and Flolan or any of its excipients 7. Cerebrovascular events (e.g., transient ischemic attack or stroke) within 6 months of screening 8. History of myocardial infarction 9. History of left-sided heart disease, including any of the following: _ hemodynamically significant aortic or mitral valve disease _ restrictive or congestive cardiomyopathy _ left ventricular ejection fraction < 40% by - multigated radionucleotide angiogram (MUGA), or - angiography, or - echocardiography _ unstable angina pectoris _ life-threatening cardiac arrhythmias 10. Chronic bleeding disorders 11. Central venous line infection within 90 days prior to screening and/or a history of recurring line infections 12. Women who are pregnant or breast-feeding 13. 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 14. Known concomitant life-threatening disease other than PAH with a life expectancy < 12 months 15. Participation in another clinical trial, except observational, or receipt of an investigational product within 30 days prior to randomization Patients who are found to be unfit for participation in this study by the doctor-in-charge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment-emergent adverse events (AEs) up to 24 hours post-EOT _ Treatment-emergent serious AEs (SAEs) up to 30 days post-EOT _ AEs leading to premature discontinuation of study drug _ Change from baseline to Visit7 in vital signs [heart rate (HR) and blood pressure (BP)] and body weight _ Change from baseline to EOT in laboratory values | — |
Countries
Japan
Outcome results
None listed