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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)

Bayer logo

Bayer

Status and phase

Completed
Phase 2

Conditions

Heart Failure

Treatments

Drug: Vericiguat (BAY1021189) (5 mg)
Drug: Placebo
Drug: Vericiguat (BAY1021189) (1.25 mg)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01951625
2013-002287-11 (EudraCT Number)
15371

Details and patient eligibility

About

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).

Enrollment

456 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

456 participants in 5 patient groups, including a placebo group

Vericiguat (BAY1021189) (10 mg)
Experimental group
Description:
2.5 mg orally once daily for 2 weeks, up-titration to 5 mg orally once daily for 2 weeks, up-titration to 10 mg orally once daily for 8 weeks
Treatment:
Drug: Vericiguat (BAY1021189) (5 mg)
Drug: Vericiguat (BAY1021189) (1.25 mg)
Vericiguat (BAY1021189) (5 mg)
Experimental group
Description:
2.5 mg orally once daily for 2 weeks, then 5 mg orally once daily for 10 weeks (with sham titration)
Treatment:
Drug: Vericiguat (BAY1021189) (5 mg)
Drug: Vericiguat (BAY1021189) (1.25 mg)
Vericiguat (BAY1021189) (2.5 mg)
Experimental group
Description:
2.5 mg orally once daily for 12 weeks (with sham titrations)
Treatment:
Drug: Vericiguat (BAY1021189) (1.25 mg)
Vericiguat (BAY1021189) (1.25 mg)
Experimental group
Description:
1.25 mg orally once daily for 12 weeks (with sham titrations)
Treatment:
Drug: Vericiguat (BAY1021189) (1.25 mg)
Placebo
Placebo Comparator group
Description:
Orally once daily for 12 weeks (with sham titrations)
Treatment:
Drug: Placebo

Trial contacts and locations

157

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Data sourced from clinicaltrials.gov

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