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A Randomized Parallel-group, Placebo-controlled, Double-blind, Multi-center Dose Finding Phase II Trial Exploring the Pharmacodynamic Effects, Safety and Tolerability, and Pharmacokinetics of Four Dose Regimens of the Oral sGC Stimulator BAY1021189 Over 12 Weeks in Patients With Worsening Heart Failure With Reduced Ejection Fraction (HFrEF)
Objective of the study is to find the optimal dose of the once daily oral soluble guanylate cyclase stimulator (sGC) BAY1021189 for Phase III that can be given in addition to standard therapy for heart failure with reduced ejection fraction (HFrEF).
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Fountain Valley, California, United States
Wilmington, Delaware, United States
Fort Lauderdale, Florida, United States
Jacksonville, Florida, United States
Naples, Florida, United States
Atlanta, Georgia, United States
Macon, Georgia, United States
New Orleans, Louisiana, United States
Detroit, Michigan, United States
Minneapolis, Minnesota, United States
Start Date
November 29, 2013
Primary Completion Date
May 14, 2015
Completion Date
June 9, 2015
Last Updated
March 25, 2021
456
ACTUAL participants
Vericiguat (BAY1021189) (1.25 mg)
DRUG
Vericiguat (BAY1021189) (5 mg)
DRUG
Placebo
DRUG
Lead Sponsor
Bayer
NCT07191730
NCT07484009
Data Source & Attribution
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