An Open-Label, Long-Term Study of Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension

United Therapeutics

Status and phase

Completed

Phase 3

Conditions

Pulmonary Arterial Hypertension

Treatments

Drug: UT-15C (treprostinil diolamine)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01560637

TDE-PH-311

Details and patient eligibility

About

This study is an international, multi-center, open-label study designed to provide oral treprostinil (UT-15C) to eligible subjects with pulmonary arterial hypertension who have completed the TDE-PH-310 study. The purpose of this study is to assess the long-term safety of UT-15C and to assess the effects of long-term treatment with UT-15C on exercise capacity.

Enrollment

471 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Participated in United Therapeutics Study TDE-PH-310
All women of childbearing potential (WOCBP) must have practiced true abstinence from intercourse when it was in line with their preferred and usual lifestyle or used 2 different forms of highly effective contraception for the duration of the study and for at least 30 days after discontinuing study medication.
Males who participated in the study must have used a condom during the length of the study and for at least 48 hours after their last dose of study medication.

Exclusion criteria

The subject was pregnant or lactating.
The subject had received infused or inhaled prostacyclin therapy for 29 days or more.
The subject was prematurely discontinued from TDE-PH-310 for reasons other than a clinical worsening event.
The subject developed a concurrent illness or condition during the conduct of TDE-PH-310 which, in the opinion of the Investigator, would represent a risk to their overall health if they enrolled in this study.