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

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.

Timeline

Start

2017-05-10

Primary completion

2018-05-23

Completion

2018-06-20

Outcome

Missed primary endpoint

paper There was no significant dose-response relationship for the change in 6-minute walk test distance among the 5 different dose-response models PMID 31162568 ↗

paper Because none of the neladenoson groups achieved the clinically relevant 40-m increase in 6-minute walk test distance from baseline, an optimal dose of neladenoson was not identified. PMID 31162568 ↗

Publications

• Shah SJ, Voors AA, McMurray JJV, Kitzman DW, Viethen T, Bomfim Wirtz A, Huang E, Pap AF, Solomon SD. Effect of Neladenoson Bialanate on Exercise Capacity Among Patients With Heart Failure With Preserved Ejection Fraction: A Randomized Clinical Trial. JAMA. 2019 Jun 4;321(21):2101-2112. doi: 10.1001/jama.2019.6717.

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

Indications