Primary or secondary pulmonary arterial hypertension, other specified pulmonary heart diseases
Conditions
Interventions
Open-label study to be conducted in patients with pulmonary arterial hypertension (PAH) who have completed the original study TDE-PH-310. There will be a single group in which 858 patients will receiv
Drug
Sponsors
Irmandade da Santa Casa de Misericórdia de Porto Alegre - ISCMPA
Pharmaceutical Research Associates Ltda.
Eligibility
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients who participated in the study TDE-PH-310 and met the definition of clinical worsening (as specified in the protocol TDE-PH-310), continued treatment with study drug, was compliant with assessments and study procedures during TDE-PH-310 or were enrolled in that study when it was discontinued by the sponsor. Women of childbearing potential must be on real abstinent or use two highly effective contraceptive methods throughout the study and for at least 30 days after discontinuation of study medication. Men participating in the study should use condoms throughout the study and for at least 48 hours after the last dose of study medication.
Exclusion criteria
Exclusion criteria: Pregnant or breastfeeding female patient. Patient receiving therapy with prostacyclin by infusion or inhalation. Patient who was early withdrawn from the study TDE-PH-310 due to reasons other than the event of clinical worsening. Patient developed a concomitant disease or condition during participation in the original study TDE-PH-310, which in the opinion of the study physician, would represent a risk to the general health if the patient were enrolled in this extension study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety assessment of study medication through the number and frequency of adverse events and changes in laboratory parameters from baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Long-term improvement in the exercise capacity as measured by the 6 minute walk test | — |
Countries
Australia, Brazil, Canada, China, France, Germany, India, Israel, Italy, Mexico, Netherlands, Republic of Korea, Taiwan, United Kingdom, United States
Contacts
Public ContactFábio Carbone de Moraes
Pharmaceutical Research Associates Ltda.
Outcome results
None listed