NCT01588405

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 1, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

May 16, 2016

Completed
Last Updated

May 16, 2016

Status Verified

April 1, 2016

Enrollment Period

2.2 years

First QC Date

January 6, 2012

Results QC Date

August 20, 2015

Last Update Submit

April 8, 2016

Conditions

Pulmonary Arterial Hypertension

Keywords

Pulmonary Arterial HypertensionUT-15C SRPAH

Outcome Measures

Primary Outcomes (1)

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

    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.

    Up to 24 weeks

Secondary Outcomes (14)

  • Change From Baseline in Six-minute Walk Distance at Week 24

    Baseline and week 24

  • Change in Borg Dyspnea Score (Following 6MWT) From Baseline to Week 24

    Baseline and week 24

  • Change in Quality of Life (QoL) Assessment: Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) 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

  • +9 more secondary outcomes

Study Arms (1)

UT-15C SR

EXPERIMENTAL
Drug: UT-15C SR

Interventions

UT-15C SRDRUG

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.

UT-15C SR

Eligibility Criteria

Age15 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • WHO functional class III and IV subjects will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Arizona Pulmonary Specialists

Phoenix, Arizona, 85013, United States

Location

University of Arizona Clinical and Translational Science (CATS) Research Center

Tucson, Arizona, 85724, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

The Ohio State University

Columbus, Ohio, 43221, United States

Location

University of Pittsburgh Medical Center (UPMC)

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Nicole Leedom
Organization
United Therapeutics
nleedom@unither.com
919-425-5870

Study Officials

  • Cynthia Madden, MD, MPH

    Senior Clinical Research Physician

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2012

First Posted

May 1, 2012

Study Start

April 1, 2012

Primary Completion

July 1, 2014

Study Completion

December 1, 2014

Last Updated

May 16, 2016

Results First Posted

May 16, 2016

Record last verified: 2016-04

Locations

US(6)