NCT03098979

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 305 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

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: 2017-05-10
• Primary completion: 2018-05-23
• Completion: 2018-06-20
• First posted: 2017-04-04
• Last updated: 2019-07-23
• Results posted: 2019-07-23

Locations

76 sites across 12 countries: United States, Austria, Belgium, Bulgaria, Germany, Greece, Israel, Italy, Japan, Poland, Portugal, Spain

Regulatory

• FDA-regulated drug study