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news.Biogen Idec and Cardiokine have initiated a Phase III multi-center, randomized, placebo controlled, double-blind study of lixivaptan for congestive heart failure patients who suffer from hyponatremia.
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The primary endpoint of the study is to evaluate the safety and effectiveness of lixivaptan, when compared to placebo, in increasing serum sodium from baseline in heart failure patients with hyponatremia. The The study also called as BALANCE study (Treatment of HyponatrEmia BAsed on LixivAptan in NYHA Class III/IV Cardiac Patient Evaluation) will compare treatment with lixivaptan to placebo in approximately 650 patients in the US and Europe.
Barry Ticho, vice president, cardiology, Biogen Idec, said: “Lixivaptan has the potential to address significant unmet needs for heart failure patients as well as other clinical conditions associated with hyponatremia.”