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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01951638
First received: September 24, 2013
Last updated: October 9, 2015
Last verified: October 2015
  Purpose
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)

Condition Intervention Phase
Heart Failure
Drug: Vericiguat (BAY1021189) (1.25 mg)
Drug: Vericiguat (BAY1021189) (5 mg)
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Change of log-transformed N-terminal pro-brain natriuretic peptide (NT-proBNP) [ Time Frame: Baseline and 12 weeks ]
  • Change of left atrial volume (LAV) [ Time Frame: Baseline and 12 weeks ]

Secondary Outcome Measures:
  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to 4 months ]

Enrollment: 477
Study Start Date: November 2013
Study Completion Date: September 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vericiguat (BAY1021189)(10 mg)
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
Drug: Vericiguat (BAY1021189) (1.25 mg)
1.25 mg BAY1021189 tablets
Drug: Vericiguat (BAY1021189) (5 mg)
5 mg BAY1021189 tablets
Experimental: Vericiguat (BAY1021189) (5 mg)
2.5 mg orally once daily for 2 weeks, then 5 mg orally once daily for 10 weeks (with sham titration)
Drug: Vericiguat (BAY1021189) (1.25 mg)
1.25 mg BAY1021189 tablets
Drug: Vericiguat (BAY1021189) (5 mg)
5 mg BAY1021189 tablets
Experimental: Vericiguat (BAY1021189) (2.5 mg)
2.5 mg orally once daily for 12 weeks (with sham titrations)
Drug: Vericiguat (BAY1021189) (1.25 mg)
1.25 mg BAY1021189 tablets
Experimental: Vericiguat (BAY1021189) (1.25 mg)
1.25 mg orally once daily for 12 weeks (with sham titrations)
Drug: Vericiguat (BAY1021189) (1.25 mg)
1.25 mg BAY1021189 tablets
Placebo Comparator: Placebo
Orally once daily for 12 weeks (with sham titrations)
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01951638

  Show 235 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Publications:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01951638     History of Changes
Other Study ID Numbers: 15829
2013-002288-25 ( EudraCT Number )
Study First Received: September 24, 2013
Last Updated: October 9, 2015

Keywords provided by Bayer:
Worsening Heart Failure
Heart Failure with Preserved Ejection Fraction

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 24, 2017