Clinical trial NCT01588405: Remodulin® to Oral Treprostinil Transition
Official title: A Multicenter, Open-Label Study of the Safety and Tolerability of Transitioning From Remodulin® to Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Arterial Hypertension
Keywords: Pulmonary Arterial Hypertension
UT-15C SR
PAH
Lead sponsor: United Therapeutics
Sponsor class: INDUSTRY
First posted: 2012-05-01
Enrollment: 33
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Participants That Were Succesfully Transitioned From Parenteral Remodulin to UT-15C.
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Change From Baseline in Six-minute Walk Distance at Week 24
timeFrame: Baseline and week 24
measure: Change in Borg Dyspnea Score (Following 6MWT) From Baseline to Week 24
timeFrame: Baseline and week 24
measure: Change in Quality of Life (QoL) Assessment: Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) From Baseline to Week 24
timeFrame: Baseline and week 24
measure: Change in World Health Organization (WHO) Functional Classification From Baseline to Week 24
timeFrame: Baseline and Week 24
measure: Change in Dyspnea-fatigue Index From Baseline to Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline to Week 24 in Pharmacokinetic Parameters: Peak Plasma Concentration (Cmax), Average Plasma Concentration (Cavg), and Trough Plasma Concentration (Cmin)
timeFrame: Baseline and Week 24
measure: Change From Baseline to Week 24 in Pharmacokinetics Parameter: Peak Time to Reach Peak Plasma Concentration [Tmax (h)]
timeFrame: Baseline and Week 24
measure: Change From Baseline to Week 24 in Pharmacokinetics Parameters: Area Under the Plasma Concentration Curve (AUC) [h(ng/mL)]
timeFrame: Baseline and Week 24
measure: 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)
timeFrame: Baseline and week 24
measure: Change From Baseline to Week 24 in Hemodynamics Parameters: Arterial Oxygen Saturation (SaO2) (%) and Mixed Venous Oxygen Saturation (SvO2) (%)
timeFrame: Baseline and Week 24
measure: Change From Baseline to Week 24 in Hemodynamics Parameters: Cardiac Output (CO) (L/Min)
timeFrame: Baseline and week 24
measure: Change From Baseline to Week 24 in Hemodynamics Parameters: Cardiac Index (CI) (L/Min/m^2)
timeFrame: Baseline and week 24
measure: Change From Baseline to Week 24 in Hemodynamics Parameters: Pulmonary Vascular Resistance Index (PVRI) (mmHg*Min*m^2/L)
timeFrame: Baseline and week 24
measure: Change From Baseline to Week 24 in Hemodynamics Parameters: Pulmonary Vascular Resistance (PVR) (mmHg*Min/L)
timeFrame: Baseline and week 24
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Pulmonary Specialists
state: Arizona
city: Tucson
country: United States
facility: University of Arizona Clinical and Translational Science (CATS) Research Center
state: Arizona
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center (UPMC)
state: Pennsylvania
Study officials:
affiliation: Senior Clinical Research Physician
name: Cynthia Madden, MD, MPH
role: STUDY_CHAIR
References: