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