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)

NCT01951638 ↗

Phase 2 Completed 477 enrolled Bayer

RandomizedParallel-groupQuadruple-blindTreatment

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 diuretic and comorbidity treatment for heart failure with preserved ejection fraction (HFpEF)

Timeline

Start: 2013-11-06
Primary completion: 2015-08-18
Completion: 2015-09-16

Outcome

Missed primary endpoint

registry analysis (other test); Placebo; p = 0.8991; Log-Scale mean difference 0.137 (90% CI -0.04 to 0.31); t-test, 1 sided NCT01951638 ↗

registry analysis (other test); Placebo; p = 0.8156; Mean Difference (Net) 1.629 (90% CI -1.36 to 4.62); t-test, 1 sided NCT01951638 ↗

Publications

Background Pieske B, Butler J, Filippatos G, Lam C, Maggioni AP, Ponikowski P, Shah S, Solomon S, Kraigher-Krainer E, Samano ET, Scalise AV, Muller K, Roessig L, Gheorghiade M; SOCRATES Investigators and Coordinators. Rationale and design of the SOluble guanylate Cyclase stimulatoR in heArT failurE Studies (SOCRATES). Eur J Heart Fail. 2014 Sep;16(9):1026-38. doi: 10.1002/ejhf.135. Epub 2014 Jul 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vericiguat	Other / unclassified	1.25 mg	Oral
Subject	Vericiguat	Other / unclassified	2.5 mg	Oral
Subject	Vericiguat	Other / unclassified	5 mg	Oral
Subject	Vericiguat	Other / unclassified	10 mg	Oral