CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 789 enrolled
Drug / intervention
Vericiguat (BAY1021189) 2.5 mg, 5 mg or 10 mg IR tablets +1 moredrug
Likely dose
Vericiguat (BAY1021189) 2.5 mg, 5 mg or 10 mg IR tabletsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03547583
NCT03547583Phase 2Completed
CompareCT.gov

A Randomized Parallel-group, Placebo-controlled, Double-blind, Multi-center Trial to Evaluate the Efficacy and Safety of the Oral sGC stImulator Vericiguat to Improve Physical Functioning in Activities of Daily Living in Patients With Heart Failure and Preserved Ejection Fraction (VITALITY-HFpEF)

Bayer·interventional·Posted Jun 6, 2018·Updated Jan 6, 2021

In Brief

A Phase 2 clinical trial evaluating Vericiguat (BAY1021189) 2.5 mg, 5 mg or 10 mg IR tablets and Placebo for Chronic Heart Failure With Preserved Ejection Fraction. Completed, enrolled 789 participants across 177 sites in 21 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Heart Failure With Preserved Ejection Fraction
CountriesArgentina, Austria, Belgium, Bulgaria, Canada, Colombia, Germany, Greece, Hungary, Israel, Italy, Japan, Malaysia, Poland, Portugal, Russia, Singapore, South Africa, Spain, Taiwan, United States
CollaboratorsMerck Sharp & Dohme LLC, Canadian VIGOUR Centre, Duke Clinical Research Institute

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJun 6, 2018
Enrollment StartJun 15, 2018
Primary CompletionOct 15, 2019
Study CompletionNov 4, 2019
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 8.1 years ago

Interventions

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

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.

Placebodrug

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