Overview

This trial is active, not recruiting.

Condition pulmonary arterial hypertension
Treatment ut-15c sr
Phase phase 2
Sponsor United Therapeutics
Start date August 2011
End date March 2013
Trial size 30 participants
Trial identifier NCT01477333, TDE-PH-203

Summary

The purpose of this multi-center, open-label, safety and tolerability study is to assess the addition of UT-15C SR to patients currently receiving Tyvaso (treprostinil) inhalation solution. The study will consist of a 24-week evaluation period followed by a long-term safety follow up. Assessments will include: hemodynamics, 6MWT, Borg dyspnea score, NT-proBNP, WHO functional class, and safety assessments.

Eligible patients will have a diagnosis of PAH, currently be receiving Tyvaso, and may be receiving other approved PAH specific oral therapies (ERAs and/or PDE-5 inhibitors, if at a stable dose for ≥ 30 days). At Baseline, subjects will receive the first dose of 0.125 mg UT-15C SR.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Safety and tolerability of the addition of UT-15C SR to Tyvaso
time frame: ≥ 24 weeks

Secondary Outcomes

Measure
Change in hemodynamic parameters
time frame: 24 weeks
Change in exercise capacity as measured by the 6- minute walk test (6MWT)
time frame: 24 weeks
Time to clinical worsening
time frame: 24 weeks
World Health Organization (WHO) functional class
time frame: 24 weeks
N-terminal pro-Brain Natriuretic Peptide (NTproBNP)
time frame: 24 weeks

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Significant inclusion criteria includes: 1. Subjects will be between 18-75 years 2. Diagnosis of PAH: Idiopathic; Heritable; Associated with: Collagen vascular disease (CVD), Human immunodeficiency virus (HIV) infection, appetite suppressant or toxin use, or repaired congenital systemic-to-pulmonary shunts (repaired ≥ 5 years) 3. Have been receiving Tyvaso for at least 4 weeks (≥ 9 breaths, QID) and require additional therapy In addition to Tyvaso, subjects may be receiving other approved PAH specific oral therapies (ERAs and/or PDE-5 inhibitors, if at a stable dose).

Additional Information

Official title An Evaluation of the Safety and Efficacy of the Addition of UT-15C SR to Pulmonary Arterial Hypertension Patients Currently Receiving Tyvaso®
Trial information was received from ClinicalTrials.gov and was last updated in February 2013.
Information provided to ClinicalTrials.gov by United Therapeutics.