Start Date
May 31, 2017
Primary Completion Date
September 30, 2018
Study Completion Date
September 30, 2018
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.
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.
Lead Sponsor
United Therapeutics
INDUSTRY