Phase IIb Safety and Efficacy Study of Four Dose Regimens of BAY1021189 in Patients With Heart Failure and Preserved Ejection Fraction Suffering From Worsening Chronic Heart Failure (SOCRATES-PRESERVED)
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | November 2013 |
| End Date: | September 2015 |
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 and Preserved Ejection Fraction (HFpEF)
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
diuretic and comorbidity treatment for heart failure with preserved ejection fraction
(HFpEF)
cyclase stimulator (sGC) BAY1021189 for Phase III that can be given in addition to standard
diuretic and comorbidity treatment for heart failure with preserved ejection fraction
(HFpEF)
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
We found this trial at
29
sites
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