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Patient-reported Outcomes in Vericiguat-treated Patients With HFpEF

NCT03547583 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 789

Last updated 2021-01-06

Study results available
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Summary

The primary hypothesis in this trial is that the treatment with vericiguat 10 mg or 15 mg in patients with HFpEF improves the KCCQ PLS (Kansas City Cardiomyopathy Questionnaire Physical limitation score) compared to placebo after 24 weeks of treatment.

Conditions

  • Chronic Heart Failure With Preserved Ejection Fraction

Interventions

DRUG

Vericiguat (BAY1021189) 2.5 mg, 5 mg or 10 mg IR tablets

Oral use. Vericiguat, which will be started at 2.5 mg at randomization and up-titrated to 5 mg at week 2, and to 10 mg at week 4, with sham titration or up-titration to 15 mg at week 6.

DRUG

Placebo

Placebo and sham up-titration at weeks 2, 4, and 6

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Canadian VIGOUR Centre

    collaborator OTHER

  • Duke Clinical Research Institute

    collaborator OTHER

  • Bayer

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-15
Primary Completion
2019-10-15
Completion
2019-11-04
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Austria
  • Belgium
  • Bulgaria
  • Canada
  • Colombia
  • Germany
  • Greece
  • Hungary
  • Israel
  • Italy
  • Japan
  • Malaysia
  • Poland
  • Portugal
  • Russia
  • Singapore
  • South Africa
  • Spain
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03547583 on ClinicalTrials.gov