A study of the drug Selexipag in patients with a disease of the heart and lung (Pulmonary Artery Hypertension)
- Conditions
- Health Condition 1: I270- Primary pulmonary hypertension
- Registration Number
- CTRI/2021/03/032147
- Lead Sponsor
- Johnson Johnson Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 5
Treated with selexipag at the end of a parent study and: a) the parent study has established efficacy with a favorable benefit/risk profile for the indication under investigation; b) participant may continue to benefit from treatment with selexipag; c) has completed the end of treatment (EOT) visit of the parent study; d) no alternative means of access to selexipag have been identified - Women of childbearing potential must use an acceptable method of contraception throughout the study and until at least 1 month following the last dose of study intervention
- Women of childbearing potential must have a negative urine (or serum if applicable) pregnancy test at screening on Day 1 or at the last visit of the parent study
- Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
- Suspected or known pulmonary veno-occlusive disease
- Known allergies, hypersensitivity, or intolerance to selexipag or its excipients
- Interruption of study intervention for more than 14 days since the last dose of study intervention taken in the parent study
- Female participant being pregnant, or breastfeeding, or planning to become pregnant at the time of screening and while enrolled in this study
- Uncontrolled thyroid disease
- Known and documented severe hepatic impairment, example, Child-Pugh Class C
- Taken any disallowed therapies, Concomitant Therapy before the planned first dose of study intervention: a) treatment with a strong CYP 2C8 inhibitor (example, gemfibrozil); b) treatment with oral prostacyclin analogs (example, beraprost, treprostinil) since the last dose of study intervention taken in the parent study; c) any investigational treatment other than selexipag
- Severe coronary heart disease or unstable angina, myocardial infarction within the last 6 months, decompensated cardiac failure if not under close medical supervision, severe arrhythmia, cerebrovascular events (example, transient ischemic attack, stroke) within the last 3 months, or congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to PH
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method -Frequency of Adverse Events (AEs) <br/ ><br>-Frequency of AEs Leading to Premature Discontinuation of Selexipag <br/ ><br>-Frequency of Serious Adverse Events (SAEs) <br/ ><br>-Frequency of Death <br/ ><br>-Number of Pregnancies with Maternal Exposure to Selexipag <br/ ><br>Timepoint: From Day 1 up to 7 years (end of study)
- Secondary Outcome Measures
Name Time Method ATimepoint: NA