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

January 6, 2012
April 4, 2014
April 2012
July 2014   (final data collection date for primary outcome measure)
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.
Incidence of Adverse Events [ 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 based on descriptive statitsics to compare the incidence of adverse events following transition relative to incidence of adverse events while subjects receiving Remodulin.
Complete list of historical versions of study NCT01588405 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Remodulin® to Oral Treprostinil Transition
A Multicenter, Open-Label Study of the Safety and Tolerability of Transitioning From Remodulin® to Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pulmonary Arterial Hypertension
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.
Experimental: UT-15C SR
Intervention: Drug: UT-15C SR
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
December 2014
July 2014   (final data collection date for primary outcome measure)

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
Both
15 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01588405
TDE-PH-205
No
United Therapeutics
United Therapeutics
Not Provided
Study Chair: Cynthia Madden, MD, MPH Senior Clinical Research Physician
United Therapeutics
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP