Oral treprostinil open label study in subjects with pulmonary arterial hypertensio
- Conditions
- Primary or secondary pulmonary arterial hypertension, other specified pulmonary heart diseasesI27.8I27.0I27.2
- Registration Number
- RBR-9q7dy5
- Lead Sponsor
- Irmandade da Santa Casa de Misericórdia de Porto Alegre - ISCMPA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
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.
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 Patient who was early withdrawn from the study TDE-PH-310 due to reasons other than the event of clinical worsening.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.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety assessment of study medication through the number and frequency of adverse events and changes in laboratory parameters from baseline.
- Secondary Outcome Measures
Name Time Method ong-term improvement in the exercise capacity as measured by the 6 minute walk test