At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 456 enrolled
Drug / intervention
Vericiguat (BAY1021189) (1.25 mg) +2 moredrug
Likely dose
Vericiguat (BAY1021189) (1.25 mg)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating Vericiguat (BAY1021189) (1.25 mg), Vericiguat (BAY1021189) (5 mg), and 1 other intervention for Heart Failure. Completed, enrolled 456 participants across 157 sites in 24 countries.
Detailed Summary
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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesAustralia, Austria, Belgium, Bulgaria, Canada, Czechia, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Japan, Netherlands, Poland, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 2013
Enrollment StartNov 2013
Primary CompletionMay 2015
Study CompletionJun 2015
TodayJul 2026
First PostedSep 26, 2013
Enrollment StartNov 29, 2013
Primary CompletionMay 14, 2015
Study CompletionJun 9, 2015
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 12.8 years ago
Interventions
Vericiguat (BAY1021189) (1.25 mg)drug
1.25 mg BAY1021189 tablets
Vericiguat (BAY1021189) (5 mg)drug
5 mg BAY1021189 tablets
Placebodrug