Phase III Clinical Worsening Study of UT-15C in Subjects With PAH Receiving Background Oral Monotherapy

Phase 3 Completed 690 enrolled United Therapeutics

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is an international, multicenter, randomized, double-blind, placebo-controlled, event driven study in subjects with pulmonary arterial hypertension.

Timeline

Start: 2012-06-26
Primary completion: 2018-06-24
Completion: 2018-06-24

Outcome

Met primary endpoint

registry analysis (superiority test); UT-15C vs Placebo; p = 0.0275; Hazard Ratio (HR) 0.74 (95% CI 0.56 to 0.97); Cox proportion-hazard model NCT01560624 ↗

paper Clinical worsening occurred in 26% of the oral treprostinil group compared with 36% of placebo participants (hazard ratio, 0.74; 95% confidence interval, 0.56-0.97; P = 0.028). PMID 31765604 ↗

release “FREEDOM-EV clinical study of Orenitram® (treprostinil) extended-release tablets in patients suffering from pulmonary arterial hypertension (PAH) has met its primary endpoint” unither.com ↗

Publications

White RJ, Jerjes-Sanchez C, Bohns Meyer GM, Pulido T, Sepulveda P, Wang KY, Grunig E, Hiremath S, Yu Z, Gangcheng Z, Yip WLJ, Zhang S, Khan A, Deng CQ, Grover R, Tapson VF; FREEDOM-EV Investigators. Combination Therapy with Oral Treprostinil for Pulmonary Arterial Hypertension. A Double-Blind Placebo-controlled Clinical Trial. Am J Respir Crit Care Med. 2020 Mar 15;201(6):707-717. doi: 10.1164/rccm.201908-1640OC.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Treprostinil	Other / unclassified	12 mg	Oral