Femme et Homme
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Extrait
Part A The safety and tolerability of 3 oral doses of BAY 94 8862 given once daily over 4 weeks in a randomized, placebo-controleld, double-blind study in subjects with chronic heart failure (CHF) with left ventricular systolic dysfunction (LVSD) and mild chronic kidney disease (CKD) (60 mL/min/7.73 m2 => eGFR <90 mL/min/1.73 m2). the effects on serum potassium, the effects of these doses on the change in biomarkers of renal function, eGFR using the Modification of Diet in Renal Disease Study Group (MDRD) formula, albuminuria, and pharmacokinetics of BAY 94 8862 and its metabolites in plasma after multiple oral doses. Part B To investigate the change of serum potassium after treatment with 4 oral dosages of BAY 94 8862 given once or twice daily over 4 weeks in a randomized, placebo-controlled, double-blind study design versus placebo in subjects with CHF with LVSD adn moderate CKD (30 mL/min/1.73 m2=<eGFR=<60 mL/min/1.73 m2).
Critère d'inclusion
- Stable chronic heart failure subjects with left ventricular systolic dysfunction and mild (Part A) or moderate (Part B) chronic kidney disease