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

NCT02992288 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 427

Last updated 2019-04-23

Study results available
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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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-22
Primary Completion
2018-03-28
Completion
2018-05-16
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Bulgaria
  • Germany
  • Greece
  • Israel
  • Italy
  • Japan
  • Netherlands
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02992288 on ClinicalTrials.gov