BAY94-8862 dose finding trial in subjects with chronic heart failure and mild (Part A) or moderate (Part B) chronic kidney disease

INTERVENTION: Product Name: BAY 94‐8862 IR tablet 1.25 mg Product Code: BAY 94‐8862 coated tablet 1.25 mg Pharmaceutical Form: Film‐coated tablet CAS Number: 1050477‐31‐0 Current Sponsor code: BAY 94‐8862 micronized Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.25‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use Product Name: BAY 94‐8862 IR tablet 10 mg Product Code: BAY 94‐8862 coated tablet 10 mg Pharmaceutical Form: Film‐coated tablet CAS Number: 1050477‐31‐0 Current Sponsor code: BAY 94‐8862 micronized Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use Trade Name: Aldactone 25 mg Product Name: Aldactone 25 mg Pharmaceutical Form: Film‐coated tablet CAS Number: 52‐01‐7 Other descriptive name: SPIRONOLACTONE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25‐ CONDITION: Stable chronic heart failure subjects with left ventricular systolic dysfunction and mild (Part A) or moderate (Part B) chronic kidney disease ; MedDRA version: 14.0 Level: LLT Classification code 10008908 Term: Chronic heart failure System Organ Class: 10007541 ‐ Cardiac disorders Therapeutic area: Diseases [C] ‐ Cardiovascular Diseases [C14] PRIMARY OUTCOME: Main Objective: 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=/= 3 months, as defined by structural or functional abnormalities of the kidney, and ‐‐ Part A: 60 mL/min/1.73 m2

Epistemonikos ID: 3a576c8214cd5a128218e25af84d835eb7face77
First added on: Aug 22, 2024