Remodulin® to Oral Treprostinil Transition

United Therapeutics

Status and phase: Completed; Phase 2

Conditions: Pulmonary Arterial Hypertension

Treatments: Drug: UT-15C SR

Study type: Interventional

Funder types: Industry

Identifiers

NCT01588405

TDE-PH-205

Details and patient eligibility

About

This multi-center, open-label study will assess the tolerability and safety of transitioning subjects with stable Pulmonary Arterial Hypertension (PAH) from continuous intravenous (IV) or subcutaneous (SC) Remodulin infusion to oral treprostinil (UT-15C sustained release (SR) tablets).

This study will consist of an in-hospital transition phase, dose optimization/evaluation phase, and follow up phase.

Enrollment: 33 patients

Sex: All

Ages: 15 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Between 15 and 80 years of age, inclusive, weigh at least 40 kg and have a diagnosis of PAH
• Have stable disease as confirmed by recent right heart catheterization and a Baseline 6MWD of at least 250 meters
• Have been receiving Remodulin for at least 90 days and at a stable dose for at least 30 days prior to the Baseline visit; the dose of Remodulin must be between 25-75 ng/kg/min, inclusive
• Must be also receiving an endothelin receptor antagonist (ERA) and/or a phosphodiesterase-5 inhibitor (PDE-5i) for at least 90 days and have been at a stable dose for at least 30 days prior to Baseline

Exclusion criteria

• WHO functional class III and IV subjects will be excluded

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

UT-15C SR

Experimental group

Treatment:

Drug: UT-15C SR