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Remodulin® to Oral Treprostinil Transition

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
United Therapeutics
ClinicalTrials.gov Identifier:
NCT01588405
First received: January 6, 2012
Last updated: April 4, 2014
Last verified: April 2014
History of Changes
  Purpose

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.


Condition Intervention Phase
Pulmonary Arterial Hypertension
 Drug: UT-15C SR
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by United Therapeutics:

Primary Outcome Measures:
  • Successful transition from parenteral Remodulin to UT-15C [ Time Frame: Up to 24 weeks; then throughout follow-up phase until study completion ] [ Designated as safety issue: Yes ]
    TO assess the tolerability and safety of transitioning subjects from Remodulin to UT-15C SR in four weeks or less.


Secondary Outcome Measures:
  • Six-minute walk distance [ Time Frame: Baseline, Weeks 0, 1, 2, 4, 8, 12, 20 and 24; then every 3 months during follow-up phase until study completion ] [ Designated as safety issue: No ]
  • Borg dyspnea score [ Time Frame: Baseline, Weeks 0, 1, 2, 4, 8, 12, 20 and 24; then every 3 months during follow-up phase until study completion ] [ Designated as safety issue: Yes ]
  • Combined walk distance / Borg dyspnea score [ Time Frame: Baseline, Weeks 0, 1, 2, 4, 8, 12, 20 and 24; then every 3 months during follow-up phase until study completion ] [ Designated as safety issue: Yes ]
  • Quality of life, assessed by the Cambridge Pulmonary Hypertension Outcome Review questionnaire & Treatment Satisfaction Questionnaire of Medication [ Time Frame: Baseline, Weeks 12 and 24; then every 3 months during follow-up phase until study completion ] [ Designated as safety issue: No ]
  • WHO functional class [ Time Frame: Baseline, Weeks 4, 8, 12, 20 and 24; then every 3 months during follow-up phase until study completion ] [ Designated as safety issue: Yes ]
  • Dyspnea-fatigue index [ Time Frame: Baseline, Weeks 4, 8, 12, 20 and 24; then every 3 months during follow-up phase until study completion ] [ Designated as safety issue: Yes ]
  • Symptoms of PAH [ Time Frame: Baseline, Weeks 0, 1, 2, 4, 8, 12, 20 and 24; then every 3 months during follow-up phase until study completion ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    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.

  • Hemodynamics [ Time Frame: Screening and Week 24 ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: up to 24 weeks; then ongoing throughout follow-up phase until study completion ] [ Designated as safety issue: Yes ]
    i.e., adverse events, clinical laboratory parameters, vital signs, echocardiograms, electrocardiograms
Estimated Enrollment: 30
Study Start Date: April 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: UT-15C SR 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.

  Eligibility
Ages Eligible for Study:   15 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01588405

Locations
United States, Arizona
Arizona Pulmonary Specialists
Phoenix, Arizona, United States, 85013
University of Arizona Clinical and Translational Science (CATS) Research Center
Tucson, Arizona, United States, 85724
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, New York
University of Rochester
Rochester, New York, United States, 14642
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43221
United States, Pennsylvania
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
United Therapeutics
Investigators
Study Chair: Cynthia Madden, MD, MPH Senior Clinical Research Physician
  More Information

No publications provided

Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT01588405     History of Changes
Other Study ID Numbers: TDE-PH-205
Study First Received: January 6, 2012
Last Updated: April 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by United Therapeutics:
Pulmonary Arterial Hypertension
UT-15C SR
PAH

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on March 01, 2015