GRIPHON 2 / Protocol AC-065A302
Research type
Research Study
Full title
A multicenter, double-blind, placebo-controlled Phase 3 study to demonstrate the efficacy and safety of ACT-293987 in patients with pulmonary arterial hypertension.
IRAS ID
35873
Contact name
Simon JR Gibbs
Eudract number
2009-014490-41
ISRCTN Number
NA
Research summary
GRIPHON 2 Study: The main purpose of this clinical research study is to show that treatment with this new drug (ACT-293987) can improve the ability to exercise in patients with pulmonary arterial hypertension (PAH) and to show that it can delay the time to worsening of the disease. Men and women above the age of 18 with PAH are invited to participate in this clinical research study that will be performed in specialist centres of excellence in the UK and other clinics around the world in 20 countries. The study will include approximately 272 patients. The study will last approximately 4 years. During that time participants will have their exercise ability assessed regularly along with blood pressure, heart performance, blood tests and quality of life.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
09/H0707/95
Date of REC Opinion
23 Mar 2010
REC opinion
Further Information Favourable Opinion