check_circleStudy Completed
Heart failure
Bayer Identifier:
16815
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Phase IIb safety and efficacy study of BAY94-8862 in subjects with worsening chronic heart failure and left ventricular systolic dysfunction and either type 2 diabetes mellitus with or without chronic kidney disease or moderate chronic kidney disease alone
Trial purpose
This study will be conducted in subjects with clinical diagnosis of worsening chronic heart failure and either type 2 diabetes mellitus (DM) with or without chronic kidney disease (CKD) or moderate CKD alone treated with evidence-based therapy for heart failure (HF) for at least 3 months prior to emergency presentation to hospital using a multi-center, randomized, adaptive, double-blind, double-dummy, comparator-controlled, parallel-group design.
Primary objective of the study is to investigate efficacy [percentage of subjects with a relative decrease in N-terminal prohormone B-type natriuretic peptide (NT-proBNP) of more than 30% from baseline to Visit 10 (Day 90)] and safety of different oral doses of BAY94-8862 given once daily.
Primary objective of the study is to investigate efficacy [percentage of subjects with a relative decrease in N-terminal prohormone B-type natriuretic peptide (NT-proBNP) of more than 30% from baseline to Visit 10 (Day 90)] and safety of different oral doses of BAY94-8862 given once daily.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
72Trial Dates
November 2013 - February 2015Phase
Phase 2Could I Receive a placebo
YesProducts
Finerenone (BAY94-8862)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Sendai, 983-8520, Japan | |
Completed | Higashiibaraki, 311-3193, Japan | |
Withdrawn | Kamogawa, 296-0041, Japan | |
Completed | Sayama, 350-1305, Japan | |
Completed | Shinjuku-ku, 162-8666, Japan | |
Completed | Kawasaki, 211-8533, Japan | |
Completed | Yokohama, 245-8575, Japan | |
Completed | Hiratsuka, 254-8502, Japan | |
Completed | Kofu, 400-8506, Japan | |
Completed | Shizuoka, 420-8630, Japan | |
Completed | Toyota, 471-8513, Japan | |
Completed | Seto, 489-8642, Japan | |
Completed | Kusatsu, 525-8585, Japan | |
Completed | Kyoto, 607-8062, Japan | |
Completed | Osaka, 558-8558, Japan | |
Completed | Amagasaki, 660-8550, Japan | |
Completed | Okayama, 700-8607, Japan | |
Completed | Fukuoka, 810-0001, Japan | |
Completed | Chikushino, 818-8516, Japan | |
Completed | Kagoshima, 892-0853, Japan | |
Completed | Urasoe, 901-2132, Japan | |
Completed | Naha, 902-8511, Japan | |
Completed | Kamogawa, 296-8602, Japan | |
Withdrawn | Sayama, 350-1305, Japan | |
Completed | Shinjuku-ku, 162-8655, Japan | |
Completed | Kobe, 650-0047, Japan | |
Completed | Matsuyama, 790-0067, Japan | |
Completed | Naha, 900-0005, Japan | |
Completed | Kobe, 654-0155, Japan | |
Completed | Funabashi, 273-8588, Japan | |
Completed | Uji, 611-0041, Japan |
Primary Outcome
- The percentage of subjects with a relative decrease in N-terminal prohormone B-type natriuretic peptide of more than 30% from baseline to Visit 10date_rangeTime Frame:From baseline to 90 daysenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Change in serum potassiumdate_rangeTime Frame:From baseline to 90 daysenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
6