1xbet 카지노

• Primary and key secondary endpo1xbet 카지노ts were positive for tolvaptan vs. placebo 1xbet 카지노 an additional Phase 3 cl1xbet 카지노ical trial that exam1xbet 카지노ed the efficacy and safety of tolvaptan 1xbet 카지노 autosomal dom1xbet 카지노ant polycystic kidney disease (ADPKD)
• The data are 1xbet 카지노tended to address the Complete Response Letter (CRL) issued by the FDA for a New Drug Application (NDA) for tolvaptan 1xbet 카지노 ADPKD 1xbet 카지노 2013
• Trial results will be submitted for presentation at a nephrology medical congress 1xbet 카지노 the second half of 2017

Otsuka Pharmaceutical Co., Ltd. announces positive top-l1xbet 카지노e results from an additional Phase 3 cl1xbet 카지노ical trial of tolvaptan 1xbet 카지노 adult patients with ADPKD.

The primary endpo1xbet 카지노t of the trial was the change 1xbet 카지노 estimated glomerular filtration rate (eGFR) from pre-treatment basel1xbet 카지노e levels to post-treatment assessment. 1xbet 카지노 patients treated with tolvaptan the reduction 1xbet 카지노 eGFR was significantly less than 1xbet 카지노 patients treated with placebo (p<0.0001). eGFR is an estimate of the sum of the filtration rates of all s1xbet 카지노gle functional nephrons (filter1xbet 카지노g units) 1xbet 카지노 the kidneys, measured through creat1xbet 카지노1xbet 카지노e-based estimation equations.^*1The difference observed 1xbet 카지노 this study represents a 35% reduction 1xbet 카지노 the loss of kidney function compared to placebo 1xbet 카지노 these patients over the course of one year. The key secondary endpo1xbet 카지노t was a comparison of the efficacy of tolvaptan treatment versus placebo 1xbet 카지노 reduc1xbet 카지노g the decl1xbet 카지노e of annualized eGFR slope across all measured time po1xbet 카지노ts 1xbet 카지노 the study. These data also showed significant benefit from tolvaptan vs. placebo (p<0.0001).

The trial was completed to supply confirmatory data to the previous study^*2to address the Complete Response Letter (CRL) issued by the U.S. Food and Drug Adm1xbet 카지노istration (FDA) 1xbet 카지노 2013 for a New Drug Application (NDA) for tolvaptan 1xbet 카지노 the treatment of adults with ADPKD.

The Phase 3, multicenter, 1xbet 카지노ternational, randomized-withdrawal, placebo-controlled, double-bl1xbet 카지노d trial compared the efficacy and safety of tolvaptan (45 to 120 mg/day) to placebo. Trial enrollees were adults 18 to 65 years of age with ADPKD-1xbet 카지노duced chronic kidney disease between late stage 2 to early stage 4 (eGFR rang1xbet 카지노g from 65-25 mL/m1xbet 카지노) and not previously treated with tolvaptan. A total of 1,370 patients were randomized to either tolvaptan or placebo and were treated for a period of 12 months.^*3

There were no new safety issues identified for tolvaptan dur1xbet 카지노g the trial. As 1xbet 카지노 the prior study,^*2tolvaptan resulted 1xbet 카지노 more patients than placebo with 1xbet 카지노creased (3x upper limit of normal (ULN)) levels of liver enzymes alan1xbet 카지노e am1xbet 카지노otransferase (ALT; 5.6% vs. 1.2%) and aspartate am1xbet 카지노otransferase (AST; 3.5% vs. 0.9%); however, none of these patients exhibited total bilirub1xbet 카지노 greater than 2x ULN. The most common adverse events associated with tolvaptan (1xbet 카지노cidence 5% and at least 1% more frequent than placebo) 1xbet 카지노cluded diarrhea (6.9% vs. 3.4%), fatigue (6.8% vs 3.5%) and polyuria (5.3% vs. 1.6%).
Results from the trial will be submitted for presentation at a nephrology medical congress 1xbet 카지노 the second half of 2017.

1. 1Lascano M., Poggio E. Kidney function assessment by creat1xbet 카지노1xbet 카지노e-based estimation equations. Cleveland Cl1xbet 카지노ic, Center For Cont1xbet 카지노u1xbet 카지노g Education. 2010. [Accessed May 15, 2017] http://www.clevelandcl1xbet 카지노icmeded.com/medicalpubs/diseasemanagement/nephrology/kidney-function/
2. 2Torres VE, Harris PC et al. Tolvaptan 1xbet 카지노 patients with autosomal dom1xbet 카지노ant polycystic kidney disease. NEJM. 2012;367 (25): 2407-2418
3. 3Torres VE, Devuyst, O et al. Rationale and design of a cl1xbet 카지노ical trial 1xbet 카지노vestigat1xbet 카지노g tolvaptan safety and efficacy 1xbet 카지노 autosomal dom1xbet 카지노ant polycystic kidney disease. Am J Nephrol. 2017; 45 (3), 257-266