drugset
drugset / Trial / NCT05179876

A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no Other Option

NCT05179876 ↗

Phase 3 Recruiting 280 enrolled Actelion
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of the study is to enable participants with pulmonary hypertension (PH) currently treated with study intervention(s) in a clinical study (parent studies \[NCT03422328, NCT03904693,NCT04565990, NCT02932410, NCT03492177, and NCT04175600\]), to continue to benefit from the intervention after closure of the parent study in case they have no alternative means of access to the study intervention. This study will allow assessment of the long-term safety of each study intervention.

Timeline

Start
2022-05-04
Primary completion
2027-01-31
Completion
2029-06-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Macitentan Other / unclassified 10 mg Oral
Subject Selexipag Small molecule 100 ug Oral
Subject Selexipag Small molecule 150 ug Oral
Subject Selexipag Small molecule 200 ug Oral
Subject Selexipag Small molecule 400 ug Oral
Subject Selexipag Small molecule 600 ug Oral
Subject Selexipag Small molecule 800 ug Oral
Subject Selexipag Small molecule 1000 ug Oral
Subject Selexipag Small molecule 1200 ug Oral
Subject Selexipag Small molecule 1400 ug Oral
Subject Selexipag Small molecule 1600 ug Oral
Subject Tadalafil Small molecule 40 mg Oral

Indications

pulmonary hypertension