A Trial to Study Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure With Reduced Ejection Fraction

Phase 2 Completed 427 enrolled Bayer

RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start: 2017-02-22
Primary completion: 2018-03-28
Completion: 2018-05-16

Outcome

Missed primary endpoint

paper After 20 weeks of treatment, there was no dose-effect of neladenoson bialanate on changes in NT-proBNP or LVEF (primary endpoints). PMID 31523892 ↗

registry p = 0.2297; NCT02992288 ↗

registry p = 0.8966; NCT02992288 ↗

Publications

Voors AA, Bax JJ, Hernandez AF, Wirtz AB, Pap AF, Ferreira AC, Senni M, van der Laan M, Butler J; PANTHEON Investigators. Safety and efficacy of the partial adenosine A1 receptor agonist neladenoson bialanate in patients with chronic heart failure with reduced ejection fraction: a phase IIb, randomized, double-blind, placebo-controlled trial. Eur J Heart Fail. 2019 Nov;21(11):1426-1433. doi: 10.1002/ejhf.1591. Epub 2019 Sep 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BAY1067197	Small molecule	5 mg	Oral
Subject	BAY1067197	Small molecule	10 mg	Oral
Subject	BAY1067197	Small molecule	20 mg	Oral
Subject	BAY1067197	Small molecule	30 mg	Oral
Subject	BAY1067197	Small molecule	40 mg	Oral