Oral UT-15C for treatment of Pulmonary Arterial Hypertension (PAH)
Research type
Research Study
Full title
A Phase III, International, Multi-Center, Randomized, Double- Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy
IRAS ID
105896
Contact name
Gerry Coghlan
Sponsor organisation
United Therapeutics Corporation
Eudract number
2012-000097-26
Clinicaltrials.gov Identifier
Research summary
Oral UT-15C for Treatment of Pulmonary Arterial Hypertension: A Phase III, International, Randomised, Double-Blind, Placebo-Controlled, Event Driven Study to Compare the Time to First Clinical Worsening in Subjects with Pulmonary Arterial Hypertension Receiving UT-15C in Combination with a PDE5-I or ERA Compared with a PDE5-I or ERA Alone. Pulmonary arterial hypertension (PAH), defined as an elevation in pulmonary arterial pressure and pulmonary vascular resistance, is a severe hemodynamic abnormality common to a variety of diseases and syndromes. Elevation in pulmonary arterial pressure causes an increase in right ventricular afterload, impairing right ventricular function and ultimately leading to heart failure and death. The purpose of this study is to compare the effectiveness of the experimental medication, oral UT-15C, against placebo in treating patients with pulmonary arterial hypertension. The study will be carried out in approximately 120 centres around the world with about 858 participants that will be invited to participate. Eligible patients will be randomly assigned to receive either the study medication(UT-15C) or the placebo. They will have a 50% chance of receiving UT-15C. The study will consist of a screening, a 24 week treatment phase and follow up visits every 12 weeks until the patient's condition worsens or they decide to withdraw from the study. Participation could last for several years and there may be the option for the patient to move onto a longterm follow up study. During the study the participants will undergo a number of procedures including a physical exam, blood tests, completion of questionnaires and a 6 minute walk test.
REC name
London - Harrow Research Ethics Committee
REC reference
12/LO/1257
Date of REC Opinion
6 Nov 2012
REC opinion
Further Information Favourable Opinion