NCT02992288

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 427 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Heart Failure

Interventions

Type	Name	Description
DRUG	Neladenoson bialanate (BAY1067197)	5 mg orally once daily for 20 weeks
DRUG	Neladenoson bialanate (BAY1067197)	10 mg orally once daily for 20 weeks
DRUG	Neladenoson bialanate (BAY1067197)	20 mg orally once daily for 20 weeks
DRUG	Neladenoson bialanate (BAY1067197)	30 mg orally once daily for 20 weeks
DRUG	Neladenoson bialanate (BAY1067197)	40 mg orally once daily for 20 weeks
DRUG	Placebo	Orally once daily for 20 weeks

Timeline

• Start date: 2017-02-22
• Primary completion: 2018-03-28
• Completion: 2018-05-16
• First posted: 2016-12-14
• Last updated: 2019-04-23
• Results posted: 2019-04-23

Locations

75 sites across 11 countries: United States, Belgium, Bulgaria, Germany, Greece, Israel, Italy, Japan, Netherlands, Poland, Spain

Regulatory

• FDA-regulated drug study