At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 305 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, Pharmacokinetics and Pharmacodynamic Effects of the Oral Partial Adenosine A1 Receptor Agonist Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure and Preserved Ejection Fraction
In Brief
A Phase 2 clinical trial evaluating Neladenoson bialanate (BAY1067197) and Placebo for Heart Failure. Completed, enrolled 305 participants across 76 sites in 12 countries.
Detailed Summary
The objective of the study is to find the optimal dose of once daily oral neladenoson bialanate (BAY1067197) when given in addition to appropriate therapy for specific comorbidities.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesAustria, Belgium, Bulgaria, Germany, Greece, Israel, Italy, Japan, Poland, Portugal, Spain, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 2017
Enrollment StartMay 2017
Primary CompletionMay 2018
Study CompletionJun 2018
TodayJul 2026
First PostedApr 4, 2017
Enrollment StartMay 10, 2017
Primary CompletionMay 23, 2018
Study CompletionJun 20, 2018
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 9.2 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