drugset / Trial / NCT02999906

Study to Compare Triple Therapy (Oral Treprostinil, Ambrisentan, and Tadalafil) With Dual Therapy (Ambrisentan, Tadalafil, and Placebo) in Subjects With Pulmonary Arterial Hypertension

NCT02999906

Phase 3 Withdrawn United Therapeutics
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a multicenter, randomized (2:1 oral treprostinil: placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are currently receiving background dual therapy (ambrisentan, tadalafil) for at least 30 days at randomization for their PAH. Once randomized, subjects will return for 5 study visits up to Week 28 during the blinded period. After the Week 28 Visit, eligible subjects will transition to the open-label period of the study for up to 20 weeks.

Timeline

Start
2017-10
Primary completion
2021-12
Completion
2022-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Treprostinil Other / unclassified Oral