The trial will evaluate Adentri, which is being developed under a licensing agreement with CV Therapeutics, or placebo in addition to standard of care in approximately 900 patients in 21 countries globally, including the US.
The Trident-1 study is a Phase III randomized, multi-center, double-blind, placebo-controlled, parallel-group study to assess the efficacy and safety of intravenous Adentri dosed up to five days on body weight in acute decompensated heart failure patients with impaired renal function.
Barry Ticho, vice president of cardiopulmonary and emerging therapies at Biogen, said: “Following lixivaptan, Adentri marks the second novel compound in Biogen Idec’s cardiopulmonary franchise that is in Phase III clinical trials for heart failure patients. We look forward to advancing this and our other programs in the future.”