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Oral Remodulin

Oral Remodulin: A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Event Driven Study to Compare the Time to First Clinical Worsening in Subjects with Pulmonary Arterial Hypertension Receiving UT-15C in Combination with a PDE5-I or ERA Compared with PDE5-I or ERA Alone.

Objective

This is a Phase III study that will look at the effects of UT-15C. UT-15C or trepostinil is a prostacyclin that causes direct vasodilatation of pulmonary and systemic arterial vascular beds and inhibition of platelet aggregation. This study will look at UT-15C in combination with other PAH treatments (PDE5-1 and ERA therapy).  Patients must be on back ground therapy with one of these two classes of medications.  Patients will then be randomized to either UT-15C or placebo. Patients in the study will be assessed for time to first clinical worsening which is defined as death, hospitalization for PAH, initiation of infused prostacyclin, disease progression, or unsatisfactory long-term clinical response. Patient’s response to therapy will also be assessed using 6 minute walk tests, WHO functional class, NT-pro BNP, and right heart catheterizations. Patient will be followed closely during the first 24 weeks with regular clinic visits and weekly telephone calls.  After 24 weeks, patients will come to the clinic every 12 weeks and have monthly telephone calls, until there is a change in the patient’s status or the study closes.  Patients that experience clinical worsening and are not started on infused prostacyclin therapy will have the opportunity to enter the extension study TDE-PH-311 (all patients will receive active drug). All patients will have the opportunity to enter the long term study once 394 clinical worsening events have been document study wide

IRB Protocol Number
12-1109

All Other Trials

  • Lungs & Respiratory
Contact
Deb McCollister, RN at 720-848-6540
or Deb.McCollister@ucdenver.edu
Eligibility and Other Participant Information

Main Inclusion Criteria:

1) Age 18-75

2) WHO Group 1

3) On background PDE-5 or ERA for at least 31 days but no more than 90 days prior to randomization.

4) mPAP >/= 25mm Hg, PVR >/= 240 dynes, PCWP or LVEDP </= 15mm Hg

Main Exclusion Criteria:

1) Received a prostacyclin within 30 days of randomization

2) Uncontrolled sleep apnea

3) ALT or AST levels >/= 3 times upper limit of normal

Location

  • University of Colorado Hospital (UCH)
    12605 E. 16th Ave.
    Aurora, CO 80045