NCT02992288|CompletedPhase 2ResultsDMCFDA Drug

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

PANTHEON

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

Bayer ClinicalTrials.gov

Compare

2 other identifiers

151282016-003839-38

Study Type

interventional

Target

427

Locations

11 countries

Sites

Timeline

RegisteredDec 2016

StartedFeb 2017

CompletionMay 2018

Brief 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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

427

participants targeted

Target at P75+ for phase_2 heart-failure

Timeline

Completed

Started Feb 2017

Shorter than P25 for phase_2 heart-failure

Geographic Reach

11 countries

75 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.2 years study duration

First Submitted

Initial submission to the registry

December 12, 2016

Completed

2 days until next milestone

First Posted

Study publicly available on registry

December 14, 2016

Completed

2 months until next milestone

Study Start

First participant enrolled

February 22, 2017

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2018

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2018

Completed

11 months until next milestone

Results Posted

Study results publicly available

April 23, 2019

Completed

Last Updated

April 23, 2019

Status Verified

April 1, 2019

Enrollment Period

1.1 years

First QC Date

December 12, 2016

Results QC Date

March 11, 2019

Last Update Submit

April 19, 2019

Conditions

Heart Failure

Keywords

Chronic Heart FailureHeart Failure with Reduced Ejection Fraction

Outcome Measures

Primary Outcomes (2)

Absolute Change From Baseline in Left Ventricular Ejection Fraction (LVEF) (%) at Week 20 Measured by Echocardiography
Left ventricular ejection fraction (LVEF) was measured by echocardiography. Mean and standard deviation were reported.
Baseline, Week 20
Absolute Change From Baseline in Log-transformed NT-pro B-type Natriuretic Peptide (BNP) at Week 20
NT-pro b-type Natriuretic Peptide (BNP) was measured. Mean and standard deviation were reported.
Baseline, Week 20

Secondary Outcomes (6)

Change From Baseline in Left Ventricular End-Systolic Volume (LVESV) at Week 20
Baseline, Week 20
Change From Baseline in Left Ventricular End-Diastolic Volume (LVEDV) at Week 20
Baseline, Week 20
Change From Baseline in High Sensitivity Troponin T (Hs-TNT) at Week 20
Baseline, Week 20
Number of Participants With Composite Efficacy Outcome
Baseline up to Week 26
Number of Participants With Cardiovascular (CV) Mortality
Baseline up to Week 26
+1 more secondary outcomes