Phase 3
N=310
Efficacy and Safety of Oral UT-15C Tablets to Treat Pulmonary Arterial Hypertension
Pulmonary Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00887978 ↗Enrolled (actual)
310
Serious AEs
14.8%
Results posted
Jan 2013
Primary outcome: Primary: 6-minute Walk Distance (6MWD) — 370; 365; 15; 11 meters — p=0.089
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- UT-15C SR (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- United Therapeutics
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 6-minute Walk Distance (6MWD) |
370; 365; 15; 11 | 0.089 |
| SECONDARY Clinical Worsening Assessment |
11; 10 | 1.00 |
| SECONDARY Borg Dyspnea Score |
3.0; 4.0; 0; 0 | 0.22 |
| SECONDARY World Health Organization (WHO) Functional Class |
1; 3; 58; 47; 70; 83 | 0.43 |
| SECONDARY Symptoms of PAH |
0.0; 0.0; -0.1; -0.2; 0.0; 0.0 | — |
| SECONDARY Dyspnea Fatigue Index |
5.7; 6.0 | 0.30 |
| SECONDARY N-terminal proBNP (NT-proBNP) |
1310; 1627; 135; 136 | — |
| SECONDARY Quality of Life (QoL) Assessment: Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) |
10.0; 9.0; 10.0; 10.0; 9.0; 5.0 | — |
Summary
This study is an international, multi-center, randomized, double-blind, placebo-controlled study in subjects with PAH who are currently receiving approved therapy for their PAH (i.e., endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor). Study visits will occur at 4 week intervals for 16 weeks with the key measure of efficacy being the 6-minute walk test. Study procedures include routine blood tests, medical history, physical exams, disease evaluation, and exercise tests.
Patients who complete all assessments for 16-weeks will also be eligible to enter an open-label, extension phase study (FREEDOM - EXT).
Eligibility Criteria
Inclusion Criteria
- A subject is eligible for inclusion in this study if all of the following criteria apply:
- Between 18 and 75 years of age, inclusive.
- Body weight at least 40 kg (approximately 90 lbs.)
- PAH that is either idiopathic/heritable; associated with appetite suppressant or toxin use; associated with collagen vascular disease; associated with repaired congenital shunts; associated with HIV.
- Currently receiving an approved endothelin receptor antagonist and/or an approved phosphodiesterase-5 inhibitor for at least 90 days and on a stable dose for at least the last 30 days.
- Baseline six-minute walk distance (6MWD) between 150-425 meters
- Previous testing (e.g., right heart catheterization, echocardiography) consistent with the diagnosis of PAH.
- Reliable and cooperative with protocol requirements.
Data sourced from ClinicalTrials.gov (NCT00887978). 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.