5 results
The objective of this study is to assess the effects of a single and chronic oral administration of S 44121 versus placebo on the occurrence of cardiac arrhythmia during standardized exercise tests (ETs) in patients with CPVT type 1. The safety…
The aim of this study is to evaluate the anti-arrhythmic efficacy of S 44121 versus placebo administered orally for a total of 12 weeks in patients with chronic heart failure and left ventricular systolic dysfunction who received an implanted…
The primary objective is to investigate the efficacy of a single intradiscal injection of STA363 into one or two IVDs as compared to placebo by the following primary efficacy endpoint:* Change from baseline at Month 6 in mean pain intensity measured…
Primary Objectives• Safety and tolerability• PK of OCA and its conjugates o SD PK Phase: To assess the PK of OCA and its conjugates after a single low dose of OCA on Day 1 and determine subject eligibility for the MD Phase o MD Phase: To assess the…
The primary objective is to assess the effects of the combination of OCA and BZF on alkaline phosphatase(ALP) in comparison to BZF alone in subjects with primary biliary cholangitis (PBC)To assess the effects of the combination of OCA and BZF in…