A Multicenter, Open-Label Study of the Safety and Tolerability of Transitioning From Remodulin® to Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension

United Therapeutics6 sites in 1 country33 target enrollmentApril 2012

ConditionsPulmonary Arterial Hypertension

InterventionsUT-15C SR

DrugsUT-15C SR

Overview

Phase: Phase 2
Intervention: UT-15C SR
Conditions: Pulmonary Arterial Hypertension
Sponsor: United Therapeutics
Enrollment: 33
Locations: 6
Primary Endpoint: Number of Participants That Were Succesfully Transitioned From Parenteral Remodulin to UT-15C.
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

April 2012

End Date

December 2014

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

United Therapeutics

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

UT-15C SR

Intervention: UT-15C SR

Outcomes

Primary Outcomes

Number of Participants That Were Succesfully Transitioned From Parenteral Remodulin to UT-15C.

Time Frame: Up to 24 weeks

Successful transition was based on the number of participants that completely transitioned to oral treprostinil by the week 4 study visit and clinically maintained on oral treprostinil treatment through Week 24.

Secondary Outcomes

Change in Quality of Life (QoL) Assessment: Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) From Baseline to Week 24(Baseline and week 24)
Change From Baseline to Week 24 in Pharmacokinetics Parameter: Peak Time to Reach Peak Plasma Concentration [Tmax (h)](Baseline and Week 24)
Change From Baseline to Week 24 in Hemodynamics Parameters: Cardiac Output (CO) (L/Min)(Baseline and week 24)
Change From Baseline to Week 24 in Pharmacokinetic Parameters: Peak Plasma Concentration (Cmax), Average Plasma Concentration (Cavg), and Trough Plasma Concentration (Cmin)(Baseline and Week 24)
Change From Baseline to Week 24 in Hemodynamics Parameters: Arterial Oxygen Saturation (SaO2) (%) and Mixed Venous Oxygen Saturation (SvO2) (%)(Baseline and Week 24)
Change From Baseline to Week 24 in Hemodynamics Parameters: Pulmonary Vascular Resistance (PVR) (mmHg*Min/L)(Baseline and week 24)
Change From Baseline in Six-minute Walk Distance at Week 24(Baseline and week 24)
Change From Baseline to Week 24 in Hemodynamics Parameters: Mean Pulmonary Artery Pressure (PAPm), Mean Right Atrial Pressure (RAPm) and Mean Pulmonary Capillary Wedge Pressure (PCWPm)(Baseline and week 24)
Change in Borg Dyspnea Score (Following 6MWT) From Baseline to Week 24(Baseline and week 24)
Change in World Health Organization (WHO) Functional Classification From Baseline to Week 24(Baseline and Week 24)
Change in Dyspnea-fatigue Index From Baseline to Week 24(Baseline and Week 24)
Change From Baseline to Week 24 in Hemodynamics Parameters: Pulmonary Vascular Resistance Index (PVRI) (mmHg*Min*m^2/L)(Baseline and week 24)
Change From Baseline to Week 24 in Pharmacokinetics Parameters: Area Under the Plasma Concentration Curve (AUC) [h(ng/mL)](Baseline and Week 24)
Change From Baseline to Week 24 in Hemodynamics Parameters: Cardiac Index (CI) (L/Min/m^2)(Baseline and week 24)