NCT03098979|CompletedPhase 2ResultsDMCFDA Drug

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

PANACHE

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

Bayer ClinicalTrials.gov

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2 other identifiers

175822016-004062-26

Study Type

interventional

Target

305

Locations

12 countries

Sites

Timeline

RegisteredApr 2017

StartedMay 2017

CompletionJun 2018

Brief 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.

Trial Health

On Track

Trial Health Score

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

Enrollment

305

participants targeted

Target at P75+ for phase_2 heart-failure

Timeline

Completed

Started May 2017

Shorter than P25 for phase_2 heart-failure

Geographic Reach

12 countries

76 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

1.1 years study duration

First Submitted

Initial submission to the registry

March 15, 2017

Completed

20 days until next milestone

First Posted

Study publicly available on registry

April 4, 2017

Completed

1 month until next milestone

Study Start

First participant enrolled

May 10, 2017

Completed

1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2018

Completed

28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2018

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

July 23, 2019

Completed

Last Updated

July 23, 2019

Status Verified

July 1, 2019

Enrollment Period

1 year

First QC Date

March 15, 2017

Results QC Date

May 23, 2019

Last Update Submit

July 4, 2019

Conditions

Heart Failure

Keywords

Chronic Heart FailureHeart Failure with Preserved Ejection Fraction

Outcome Measures

Primary Outcomes (1)

Absolute Change From Baseline in 6-minute Walking Distance (6MWD) After 20 Weeks of Treatment
The 6MWD test is designed to evaluate a subject's exercise capacity while performing an everyday activity.
Baseline, and up to 20 weeks of treatment

Secondary Outcomes (4)

Change From Baseline in Average Weekly Percentage of Maximum Possible Recorded Activity Intensity
Baseline, and up to 20 weeks of treatment
Measured Values (Log Transformed) and Absolute Change in NT-proBNP From Baseline to 20 Weeks
Baseline, and up to 20 weeks of treatment
Measured Values (Log-transformed) and Absolute Change in High Sensitivity Troponin T (Hs-TNT) From Baseline to 20 Weeks
Baseline, and up to 20 weeks of treatment
Measured Values and Absolute Change in 3 Scores From Kansas City Cardiomyopathy Questionnaire (KCCQ) From Baseline to 20 Weeks: Overall Summary Score, Physical Limitation Score and Total Symptom Score
Baseline, and up to 20 weeks of treatment