TDE-PH-308 (FREEDOM 308)
Research type
Research Study
Full title
TDE-PH-308: A 16-Week, International, Multicentre, Double-Blind, Randomised, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension
IRAS ID
26468
Contact name
Andrew J Peacock
Eudract number
2009-009366-13
ISRCTN Number
Not applicable
Clinicaltrials.gov Identifier
Research summary
TDE-PH-308 - Is a 16-Week, international, multicentre, double-blind, randomised, placebo-controlled study of the efficacy and safety of oral UT-15C sustained release tablets in subjects with pulmonary arterial hypertension (PAH). PAH, which is 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 inactivity, right ventricular failure and death. Treprostinil Diethanolamine (UT-15C SR), an investigational drug, has been extensively characterised in well established models all confirming the suitability of the drug in the treatment of PAH following either the subcutaneous, intravenous, inhaled (all as treprostinil sodium) or oral (as treprostinil diethanolamine) routes of administration. This investigational drug is a tablet that is to be taken orally and its treatment effect is released over an extended period of time (sustained release, or SR). Approximately 300 participants will be included in this study from the Israel, Australia, Europe, USA and Canada. Participation in this study is voluntary and will last approximately 16 weeks from the start until the end of the study. The study is placebo controlled, meaning that one group of participants (approximately 50%) will receive UT-15C SR, whilst the other group (approximately 50%) will receive tablets that appear the same but do not contain active drug.
REC name
West of Scotland REC 1
REC reference
09/S0703/93
Date of REC Opinion
13 Aug 2009
REC opinion
Favourable Opinion