10 results
The objective of this pivotal study is to assess the PK and PD as well as safety and tolerability of RP103 compared to Cystagon® in patients with nephropathic cystinosis. Results of this Phase 3 study will be used to support the registration…
Demonstrate whether, in addition to standard of care, finerenone is superior to placebo in delaying the time to first occurrence of cardiovascular mortality and morbidity in subjects with T2DM and the clinical diagnosis of DKD.
Demonstrate whether, in addition to standard of care (SoC), finerenone is superior to placebo in delaying the progression of kidney disease, as measured by the composite endpoint of time to first occurrence of kidney failure, a sustained decrease of…
The purpose of this study is to investigate the safety and tolerability of different doses of neosaxitoxin when it is administered to healthy male volunteers alone and in combination with bupivacaine (with and without epinephrine) in perineural…
Demonstrate the superiority of finerenone to eplerenone in delaying time to first occurrence of the compositeendpoint, defined as cardiovascular (CV) death or hospitalization for heart failure (HF), in patients withCHF (NYHA class II-IV) and reduced…
- To assess the pharmacokinetic profile of cysteamine base after single dose administration of the new sustained-release cysteamine bitartrate (PO-001) to healthy volunteers, in comparison with Cystagon® and Procysbi®.- To collect safety/…
The main goal of this study is to find out whether finerenone in combination with either an ACE inhibitor or an ARB can reduce the amount of protein in the participants' urine more than a placebo. A placebo looks like a drug, but contains no…
Main objective:The primary objective is to demonstrate that combination therapy using finerenone and empagliflozin is superior in reducing UACR than either empagliflozin or finerenone alone.Secondary objectives:- To further investigate the efficacy…
To demonstrate the superiority of finerenone to placebo in reducing the rate of the composite CV endpoint.To determine superiority of finerenone to placebo for each secondary endpointTo assess the safety and tolerability of finerenone
A study to learn more about how safe the study treatment finerenone is inlong-term use when taken with an ACE inhibitor or angiotensin receptorblocker over 18 months of use in children and young adults from 1 to 18years of age with chronic kidney…