Safety of Transition From Selexipag to Remodulin® Then Oral Treprostinil in Symptomatic Adult PAH

PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

May 31, 2017

Primary Completion Date

September 30, 2018

Study Completion Date

September 30, 2018

Conditions
Pulmonary Arterial Hypertension
Interventions
DRUG

Parenteral Remodulin (treprostinil) injection

Remodulin will be provided in vial strengths of 1, 2.5, 5, and 10 mg/mL. Subjects will be admitted to the hospital and IV Remodulin will be initiated within 12 hours after the last dose of selexipag. Subjects will remain under observation in the inpatient setting for at least the first 72 hours of Remodulin administration. Subjects will be transitioned to an equivalent dose of SC Remodulin at discharge.

DRUG

Oral Treprostinil

Oral treprostinil will be provided as 0.125-, 0.25-, 1-, or 2.5-mg extended-release tablets. Oral treprostinil will be dosed three times daily with food.

Sponsors
All Listed Sponsors
lead

United Therapeutics

INDUSTRY