Phase 2
N=456
Phase IIb Safety and Efficacy Study of Four Dose Regimens of BAY1021189 in Patients With Heart Failure With Reduced Ejection Fraction Suffering From Worsening Chronic Heart Failure (SOCRATES-REDUCED)
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT01951625 ↗Enrolled (actual)
456
Serious AEs
27.9%
Results posted
Mar 2021
Primary outcome: Primary: Change From Baseline in Log-Transformed N-Terminal Pro-Brain Natriuretic Peptide (NTproBNP) to Week 12 — -0.28; -0.265; -0.32; -0.353 log-transformed picograms per milliliter — p== 0.1506
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Vericiguat (BAY1021189) (1.25 mg) (Drug); Vericiguat (BAY1021189) (5 mg) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Log-Transformed N-Terminal Pro-Brain Natriuretic Peptide (NTproBNP) to Week 12 |
-0.28; -0.265; -0.32; -0.353; -0.529; -0.402 | = 0.1506 |
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).
Eligibility Criteria
Inclusion Criteria
- Worsening chronic heart failure (WCHF) requiring hospitalization (or intravenous diuretic treatment for HF without hospitalization) with initiation of study treatment after clinical stabilization
- Left ventricular ejection fraction (LVEF) <45% by echocardiography at randomization
Exclusion Criteria
- Intravenous inotropes at any time after hospitalization
Data sourced from ClinicalTrials.gov (NCT01951625). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.