At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 427 enrolled
Drug / intervention
Neladenoson bialanate (BAY1067197) +5 moredrug
Likely dose
Neladenoson bialanate (BAY1067197) 5 mgfrom 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.
A Multicenter, Randomized, Placebo-controlled, Parallel Group, Double Blind, Dose-finding Phase II Trial to Study the Efficacy, Safety, Pharmacokinetic and Pharmacodynamic Effects of the Oral Partial Adenosine A1 Receptor Agonist Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure With Reduced Ejection Fraction
In Brief
A Phase 2 clinical trial evaluating Neladenoson bialanate (BAY1067197) and Placebo for Heart Failure. Completed, enrolled 427 participants across 75 sites in 11 countries.
Detailed Summary
The objective of the study is to find the optimal dose of once daily oral neladenoson bialanate (BAY 1067197) when given in addition to standard therapy for heart failure with reduced ejection fraction (HFrEF).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesBelgium, Bulgaria, Germany, Greece, Israel, Italy, Japan, Netherlands, Poland, Spain, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 2016
Enrollment StartFeb 2017
Primary CompletionMar 2018
Study CompletionMay 2018
TodayJul 2026
First PostedDec 14, 2016
Enrollment StartFeb 22, 2017
Primary CompletionMar 28, 2018
Study CompletionMay 16, 2018
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 9.5 years ago
Interventions
Neladenoson bialanate (BAY1067197)drug
5 mg orally once daily for 20 weeks
Neladenoson bialanate (BAY1067197)drug
10 mg orally once daily for 20 weeks
Neladenoson bialanate (BAY1067197)drug
20 mg orally once daily for 20 weeks
Neladenoson bialanate (BAY1067197)drug
30 mg orally once daily for 20 weeks
Neladenoson bialanate (BAY1067197)drug
40 mg orally once daily for 20 weeks
Placebodrug
Orally once daily for 20 weeks