Lixivaptan BALANCE study is a 650-patient Phase III, global, multi-center, randomized, placebo-controlled, double-blind, study of lixivaptan for hyponatremia in patients with heart failure. The primary objective is to evaluate the safety and effectiveness of lixivaptan, when compared to the placebo, in increasing serum sodium from baseline in heart failure patients with hyponatremia. In previous studies, lixivaptan improved blood sodium levels, lowered body weight and increased urine volume. Those studies suggest that lixivaptan may play an important role in treating hyponatremia and the signs and symptoms of water retention associated with heart failure, Syndrome of Inappropriate Anti-Diuretic Hormone(SIADH), and Liver Cirrhosis with
Fetal bovine serum and virus, endotoxin, haemoglobin, IgG and total protein assays. Ethical questions have been raised regarding the blood collection process due to the potential suffering caused to the fetus. Although anoxia or active slaughter could be used to induce unconsciousness or death prior to serum harvesting, exposure of live unborn calves to oxygen can cause them to gain awareness before being killed, resulting in active debate about the ethics of harvesting serum. Fetal bovine serum is commercially available from many manufacturers, and because cells grown in vitro are highly sensitive, customers usually test specific batches to check for suitability for their