TRITON- Macitentan, Tadalafil and Selexipag Study in Patients with PAH
Research type
Research Study
Full title
The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension: A Multi-Centre, double-blind, placebo-controlled, Phase 3b Study.
IRAS ID
236384
Contact name
Luke Howard
Contact email
Sponsor organisation
Actelion Pharmaceuticals Ltd
Eudract number
2015-003438-28
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
Pulmonary Arterial Hypertension (PAH) is a rare disorder of the blood vessels in the lungs which affects 15-50 people per million. PAH occurs when the blood pressure in the pulmonary arteries becomes higher than normal. Through time, scarring of the blood vessels makes them stiffer and thicker, and some may become completely locked. These less flexible blood vessels make it more difficult for blood to get through to the lungs, and the heart must pump harder. The extra stress of pumping harder causes the heart to enlarge and start to work poorly. As this disease progresses, less and less blood is able to flow out of the heart, through the lungs, and into the body, and more symptoms begin to appear. If not diagnosed early and/or left untreated, the patients' condition will deteriorate rapidly, which can ultimately lead to right heart failure and premature death.
The Primary objective of this study is to compare the effect on pulmonary Vascular Resistance (PVR) of an initial triple oral regimen versus an initial dual oral regimen in newly diagnosed, treatment-naïve subjects with Pulmonary Arterial Hypertension (PAH).
The study duration will be approximately 4 years, based on an assumed enrollment period of 3 years. Approximately 238 patients will be randomized in a 1:1 ratio to the two treatment groups (approximately 119 patients per group)
REC name
London - City & East Research Ethics Committee
REC reference
18/LO/1063
Date of REC Opinion
21 Jun 2018
REC opinion
Favourable Opinion