Phase 2
Completed N=33
Remodulin® to Oral Treprostinil Transition
Source: ClinicalTrials.gov NCT01588405 ↗Enrolled (actual)
33
Serious AEs
27.3%
Results posted
May 2016
Primary outcomePrimary: Number of Participants That Were Succesfully Transitioned From Parenteral Remodulin to UT-15C. — 31 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants That Were Succesfully Transitioned From Parenteral Remodulin to UT-15C. |
31 | — |
| SECONDARY Change From Baseline in Six-minute Walk Distance at Week 24 |
467; 16.7 | — |
| SECONDARY Change in Borg Dyspnea Score (Following 6MWT) From Baseline to Week 24 |
0.0 | — |
| SECONDARY Change in Quality of Life (QoL) Assessment: Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) From Baseline to Week 24 |
-1.0; 0.0; 0.0; -2.0 | — |
| SECONDARY Change in World Health Organization (WHO) Functional Classification From Baseline to Week 24 |
3; 2; 1; 3; 21; 1 | — |
| SECONDARY Change in Dyspnea-fatigue Index From Baseline to Week 24 |
1.0 | — |
| SECONDARY Change From Baseline to Week 24 in Pharmacokinetic Parameters: Peak Plasma Concentration (Cmax), Average Plasma Concentration (Cavg), and Trough Plasma Concentration (Cmin) |
8.76; 13; 12.1; 7.22; 6.89; 6.64 | — |
| SECONDARY Change From Baseline to Week 24 in Pharmacokinetics Parameter: Peak Time to Reach Peak Plasma Concentration [Tmax (h)] |
4.01; 5.60; 3.92 | — |
| SECONDARY Change From Baseline to Week 24 in Pharmacokinetics Parameters: Area Under the Plasma Concentration Curve (AUC) [h(ng/mL)] |
86.3; 82.5; 81.8 | — |
| SECONDARY 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) |
2.2; 0.5; 0.6 | — |
| SECONDARY Change From Baseline to Week 24 in Hemodynamics Parameters: Arterial Oxygen Saturation (SaO2) (%) and Mixed Venous Oxygen Saturation (SvO2) (%) |
-0.1; -3.2 | — |
| SECONDARY Change From Baseline to Week 24 in Hemodynamics Parameters: Cardiac Output (CO) (L/Min) |
-0.3 | — |
| SECONDARY Change From Baseline to Week 24 in Hemodynamics Parameters: Cardiac Index (CI) (L/Min/m^2) |
-0.1 | — |
| SECONDARY Change From Baseline to Week 24 in Hemodynamics Parameters: Pulmonary Vascular Resistance Index (PVRI) (mmHg*Min*m^2/L) |
1.6 | — |
| SECONDARY Change From Baseline to Week 24 in Hemodynamics Parameters: Pulmonary Vascular Resistance (PVR) (mmHg*Min/L) |
0.8 | — |
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
Data sourced from ClinicalTrials.gov (NCT01588405). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.