Remodulin® to Oral Treprostinil Transition

Pulmonary Arterial Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01588405
• Other study ID #: TDE-PH-205
• Status: Completed
• Phase: Phase 2
• First received: January 6, 2012
• Last updated: March 20, 2015
• Start date: April 2012
• Est. completion date: December 2014

Study information

• Verified date: March 2015
• Source: United Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Drug:
• UT-15C SR
Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio
United States	Arizona Pulmonary Specialists	Phoenix	Arizona
United States	University of Pittsburgh Medical Center (UPMC)	Pittsburgh	Pennsylvania
United States	University of Rochester	Rochester	New York
United States	Washington University School of Medicine	St. Louis	Missouri
United States	University of Arizona Clinical and Translational Science (CATS) Research Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
United Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful transition from parenteral Remodulin to UT-15C	TO assess the tolerability and safety of transitioning subjects from Remodulin to UT-15C SR in four weeks or less.	Up to 24 weeks; then throughout follow-up phase until study completion	Yes
Secondary	Six-minute walk distance		Baseline, Weeks 0, 1, 2, 4, 8, 12, 20 and 24; then every 3 months during follow-up phase until study completion	No
Secondary	Borg dyspnea score		Baseline, Weeks 0, 1, 2, 4, 8, 12, 20 and 24; then every 3 months during follow-up phase until study completion	Yes
Secondary	Combined walk distance / Borg dyspnea score		Baseline, Weeks 0, 1, 2, 4, 8, 12, 20 and 24; then every 3 months during follow-up phase until study completion	Yes
Secondary	Quality of life, assessed by the Cambridge Pulmonary Hypertension Outcome Review questionnaire & Treatment Satisfaction Questionnaire of Medication		Baseline, Weeks 12 and 24; then every 3 months during follow-up phase until study completion	No
Secondary	WHO functional class		Baseline, Weeks 4, 8, 12, 20 and 24; then every 3 months during follow-up phase until study completion	Yes
Secondary	Dyspnea-fatigue index		Baseline, Weeks 4, 8, 12, 20 and 24; then every 3 months during follow-up phase until study completion	Yes
Secondary	Symptoms of PAH		Baseline, Weeks 0, 1, 2, 4, 8, 12, 20 and 24; then every 3 months during follow-up phase until study completion	Yes
Secondary	Pharmacokinetics	Blood samples to be drawn from each subject at time 0 and times 2, 4, 5, 6, 8 and 12 hours after time 0 for a total of 7 samples.	Baseline and Week 24	No
Secondary	Hemodynamics		Screening and Week 24	No
Secondary	Safety	i.e., adverse events, clinical laboratory parameters, vital signs, echocardiograms, electrocardiograms	up to 24 weeks; then ongoing throughout follow-up phase until study completion	Yes