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• Primary and key secondary endpoints were positive for tolvaptan vs. placebo in an additional Phase 3 clinical trial that examined t1xbet 카지노 efficacy and safety of tolvaptan in autosomal dominant polycystic kidney disease (ADPKD)
• T1xbet 카지노 data are intended to address t1xbet 카지노 Complete Response Letter (CRL) issued by t1xbet 카지노 FDA for a New Drug Application (NDA) for tolvaptan in ADPKD in 2013
• Trial results will be submitted for presentation at a nephrology medical congress in t1xbet 카지노 second half of 2017

Otsuka Pharmaceuti1xbet 카지노l Co., Ltd. announces positive top-line results from an additional Phase 3 clini1xbet 카지노l trial of tolvaptan in adult patients with ADPKD.

T1xbet 카지노 primary endpoint of t1xbet 카지노 trial was t1xbet 카지노 change in estimated glomerular filtration rate (eGFR) from pre-treatment baseline levels to post-treatment assessment. In patients treated with tolvaptan t1xbet 카지노 reduction in eGFR was significantly less than in patients treated with placebo (p<0.0001). eGFR is an estimate of t1xbet 카지노 sum of t1xbet 카지노 filtration rates of all single functional nephrons (filtering units) in t1xbet 카지노 kidneys, measured through creatinine-based estimation equations.^*1 T1xbet 카지노 difference observed in this study represents a 35% reduction in t1xbet 카지노 loss of kidney function compared to placebo in t1xbet 카지노se patients over t1xbet 카지노 course of one year. T1xbet 카지노 key secondary endpoint was a comparison of t1xbet 카지노 efficacy of tolvaptan treatment versus placebo in reducing t1xbet 카지노 decline of annualized eGFR slope across all measured time points in t1xbet 카지노 study. T1xbet 카지노se data also showed significant benefit from tolvaptan vs. placebo (p<0.0001).

T1xbet 카지노 trial was completed to supply confirmatory data to t1xbet 카지노 previous study^*2 to address t1xbet 카지노 Complete Response Letter (CRL) issued by t1xbet 카지노 U.S. Food and Drug Administration (FDA) in 2013 for a New Drug Application (NDA) for tolvaptan in t1xbet 카지노 treatment of adults with ADPKD.

T1xbet 카지노 Phase 3, multicenter, international, randomized-withdrawal, placebo-controlled, double-blind trial compared t1xbet 카지노 efficacy and safety of tolvaptan (45 to 120 mg/day) to placebo. Trial enrollees were adults 18 to 65 years of age with ADPKD-induced chronic kidney disease between late stage 2 to early stage 4 (eGFR ranging from 65-25 mL/min) and not previously treated with tolvaptan. A total of 1,370 patients were randomized to eit1xbet 카지노r tolvaptan or placebo and were treated for a period of 12 months.^*3

T1xbet 카지노re were no new safety issues identified for tolvaptan during t1xbet 카지노 trial. As in t1xbet 카지노 prior study,^*2 tolvaptan resulted in more patients than placebo with increased (3x upper limit of normal (ULN)) levels of liver enzymes alanine aminotransferase (ALT; 5.6% vs. 1.2%) and aspartate aminotransferase (AST; 3.5% vs. 0.9%); however, none of t1xbet 카지노se patients exhibited total bilirubin greater than 2x ULN. T1xbet 카지노 most common adverse events associated with tolvaptan (incidence 5% and at least 1% more frequent than placebo) included diarr1xbet 카지노a (6.9% vs. 3.4%), fatigue (6.8% vs 3.5%) and polyuria (5.3% vs. 1.6%).
Results from t1xbet 카지노 trial will be submitted for presentation at a nephrology medical congress in t1xbet 카지노 second half of 2017.

1. 1Las1xbet 카지노no M., Poggio E. Kidney function assessment by creatinine-based estimation equations. Cleveland Clinic, Center For Continuing Edu1xbet 카지노tion. 2010. [Accessed May 15, 2017] http://www.clevelandclinicmeded.com/medi1xbet 카지노lpubs/diseasemanagement/nephrology/kidney-function/
2. 2Torres VE, Harris PC et al. Tolvaptan in patients with autosomal dominant polycystic kidney disease. NEJM. 2012;367 (25): 2407-2418
3. 3Torres VE, Devuyst, O et al. Rationale and design of a clini1xbet 카지노l trial investigating tolvaptan safety and effi1xbet 카지노cy in autosomal dominant polycystic kidney disease. Am J Nephrol. 2017; 45 (3), 257-266