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

Primary Purpose

Heart Failure

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Neladenoson bialanate (BAY1067197)
Neladenoson bialanate (BAY1067197)
Neladenoson bialanate (BAY1067197)
Neladenoson bialanate (BAY1067197)
Neladenoson bialanate (BAY1067197)
Placebo
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Chronic Heart Failure, Heart Failure with Reduced Ejection Fraction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men or women aged 18 years and older
  • Diagnosis of chronic heart failure (CHF), NYHA ( New York Heart Association ) class II-IV, LVEF ≤ 35% and elevated NT-proBNP

Exclusion Criteria:

  • Acute de-novo heart failure
  • Requirement of any intravenous (IV) treatments following 48 hours prior to randomization
  • Mechanical support (e.g. intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, or any ventricular assist device)
  • Any cause of chronic heart failure other than ischemic cardiomyopathy and idiopathic dilated cardiomyopathy

Sites / Locations

  • Southwest Florida Research
  • Henry Ford Health System
  • University of Mississippi Medical Center
  • St. Louis Heart & Vascular, PC
  • Glacier View Research Institute-Cardiology
  • Stony Brook University Medical Center
  • St. Elizabeth Youngstown Hospital
  • Tennessee Center for Clinical Trials
  • East Texas Cardiology
  • AZ St-Jan Brugge Oostende AV
  • Grand Hôpital de Charleroi
  • AZ Delta
  • AZ Turnhout
  • Spec Hosp for Active Treatm in Cardiology Sv Georgi Pernik
  • Specialized Hospital for Actrive Treatm of Card - Pleven
  • NMTH Tzar Boris III
  • UMHAT Tsaritsa Joanna-ISUL EAD Sofia
  • Multiprofile Hospital for Active Treatment Sveta Sofia
  • MHAT Dr Stefan Cherkezov
  • Medizinische Hochschule Hannover (MHH)
  • Herz- und Diabeteszentrum Nordrhein-Westfalen (HDZ NRW)
  • St.-Johannes-Hospital Dortmund
  • Kliniken Maria Hilf GmbH
  • Klinikum der Stadt Ludwigshafen am Rhein gGmbH
  • Charité Campus Virchow-Klinikum (CVK)
  • KAT General Hospital of Athens
  • G. Gennimatas General State Hospital of Athens
  • Thriassio General Hospital of Elefsina
  • Konstantopoulio General Hospital of Nea Ionia - Agia Olga
  • Hippokration General Hospital of Thessaloniki
  • Barzilai Medical Center
  • Hillel Yaffe Medical Center
  • Rambam Health Corporation
  • Shaare Zedek Medical Center
  • Hadassah University Hospital Mount Scopus
  • Tel-Aviv Sourasky Medical Center
  • Assaf Harofeh Medical Center
  • A.O.U. Policlinico Federico II Napoli
  • Fondazione Policlinico Universitario Agostino Gemelli
  • ASST Papa Giovanni XXIII
  • ASST Spedali Civili di Brescia
  • IRCCS Centro Cardiologico Fondazione Monzino
  • AUSL 8 Arezzo
  • Gunma University Hospital
  • National Hospital Organization Takasaki General Medical C
  • Hyogo Prefectural Amagasaki General Medical Center
  • National hospital Organization Mito Medical Center
  • R.I.A.C Naha City Hospital
  • Kishiwada Tokushukai Hospital
  • Takatsuki Red Cross Hospital
  • Minamino Cardiovascular Hospital
  • Nihon University Itabashi Hospital
  • Tokyo Women's Medical University Hospital
  • Hiroshima University Hospital
  • Okayama Rosai Hospital
  • Osaka General Medical Center
  • Toyama Prefectural Central Hospital
  • Onze Lieve Vrouwe Gasthuis
  • Ziekenhuis Rijnstate
  • Universitair Medisch Centrum Groningen
  • Erasmus Medisch Centrum
  • KLIMED Marek Klimkiewicz
  • CLINICAL MEDICAL RESEARCH Sp. z o. o.
  • Szpital Specjalistyczny im. J. Dietla
  • Nzoz Salus
  • Szpital Kliniczny Przemienienia Panskiego
  • Twoja Przychodnia - Szczecinskie Centrum Medyczne
  • IV Wojskowy Szpital Kliniczny z Poliklinika, SPZOZ
  • Hospital Clínico Universitario de Santiago de Compostela
  • Hospital Universitario "Virgen de la Arrixaca"
  • Complejo Hospitalario Universitario A Coruña
  • Hospital General Universitario Gregorio Marañón
  • Hospital Clínico Universitario San Carlos
  • Hospital Clínico Universitario de Valencia
  • Hospital Universitari i Politècnic La Fe

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Neladenoson bialanate (BAY1067197) (5 mg)

Neladenoson bialanate (BAY1067197) (10 mg)

Neladenoson bialanate (BAY1067197) (20 mg)

Neladenoson bialanate (BAY1067197) (30 mg)

Neladenoson bialanate (BAY1067197) (40 mg)

Placebo

Arm Description

Chronic heart failure with reduced ejection fraction

Chronic heart failure with reduced ejection fraction

Chronic heart failure with reduced ejection fraction

Chronic heart failure with reduced ejection fraction

Chronic heart failure with reduced ejection fraction

Chronic heart failure with reduced ejection fraction

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Change From Baseline in Left Ventricular End-Systolic Volume (LVESV) at Week 20
LVESV was defined as the volume of blood in the left ventricle at the end of contraction, or systole and the beginning of filling or diastole. Mean and standard deviation were reported.
Change From Baseline in Left Ventricular End-Diastolic Volume (LVEDV) at Week 20
LVEDV was defined as the volume of blood in the left ventricle at end load or filling in diastole or the amount of blood in the ventricles just before systole. Mean and standard deviation were reported.
Change From Baseline in High Sensitivity Troponin T (Hs-TNT) at Week 20
High sensitivity troponin T (hs-TNT) was measured. Mean and standard deviation were reported.
Number of Participants With Composite Efficacy Outcome
Composite efficacy outcome was the first occurrence of CV death, HF hospitalization or urgent visit for HF. Number of participants with composite efficacy outcome were reported.
Number of Participants With Cardiovascular (CV) Mortality
Cardiovascular (CV) mortality was assessed. Number of participants with CV mortality were reported.
Number of Participants With Heart Failure (HF) Hospitalization and Urgent Visits for Heart Failure (HF)
Number of participants with HF hospitalization and urgent visits for HF were reported.

Full Information

First Posted
December 12, 2016
Last Updated
April 19, 2019
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT02992288
Brief Title
A Trial to Study Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure With Reduced Ejection Fraction
Acronym
PANTHEON
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
February 22, 2017 (Actual)
Primary Completion Date
March 28, 2018 (Actual)
Study Completion Date
May 16, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Chronic Heart Failure, Heart Failure with Reduced Ejection Fraction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
427 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neladenoson bialanate (BAY1067197) (5 mg)
Arm Type
Experimental
Arm Description
Chronic heart failure with reduced ejection fraction
Arm Title
Neladenoson bialanate (BAY1067197) (10 mg)
Arm Type
Experimental
Arm Description
Chronic heart failure with reduced ejection fraction
Arm Title
Neladenoson bialanate (BAY1067197) (20 mg)
Arm Type
Experimental
Arm Description
Chronic heart failure with reduced ejection fraction
Arm Title
Neladenoson bialanate (BAY1067197) (30 mg)
Arm Type
Experimental
Arm Description
Chronic heart failure with reduced ejection fraction
Arm Title
Neladenoson bialanate (BAY1067197) (40 mg)
Arm Type
Experimental
Arm Description
Chronic heart failure with reduced ejection fraction
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Chronic heart failure with reduced ejection fraction
Intervention Type
Drug
Intervention Name(s)
Neladenoson bialanate (BAY1067197)
Intervention Description
5 mg orally once daily for 20 weeks
Intervention Type
Drug
Intervention Name(s)
Neladenoson bialanate (BAY1067197)
Intervention Description
10 mg orally once daily for 20 weeks
Intervention Type
Drug
Intervention Name(s)
Neladenoson bialanate (BAY1067197)
Intervention Description
20 mg orally once daily for 20 weeks
Intervention Type
Drug
Intervention Name(s)
Neladenoson bialanate (BAY1067197)
Intervention Description
30 mg orally once daily for 20 weeks
Intervention Type
Drug
Intervention Name(s)
Neladenoson bialanate (BAY1067197)
Intervention Description
40 mg orally once daily for 20 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Orally once daily for 20 weeks
Primary Outcome Measure Information:
Title
Absolute Change From Baseline in Left Ventricular Ejection Fraction (LVEF) (%) at Week 20 Measured by Echocardiography
Description
Left ventricular ejection fraction (LVEF) was measured by echocardiography. Mean and standard deviation were reported.
Time Frame
Baseline, Week 20
Title
Absolute Change From Baseline in Log-transformed NT-pro B-type Natriuretic Peptide (BNP) at Week 20
Description
NT-pro b-type Natriuretic Peptide (BNP) was measured. Mean and standard deviation were reported.
Time Frame
Baseline, Week 20
Secondary Outcome Measure Information:
Title
Change From Baseline in Left Ventricular End-Systolic Volume (LVESV) at Week 20
Description
LVESV was defined as the volume of blood in the left ventricle at the end of contraction, or systole and the beginning of filling or diastole. Mean and standard deviation were reported.
Time Frame
Baseline, Week 20
Title
Change From Baseline in Left Ventricular End-Diastolic Volume (LVEDV) at Week 20
Description
LVEDV was defined as the volume of blood in the left ventricle at end load or filling in diastole or the amount of blood in the ventricles just before systole. Mean and standard deviation were reported.
Time Frame
Baseline, Week 20
Title
Change From Baseline in High Sensitivity Troponin T (Hs-TNT) at Week 20
Description
High sensitivity troponin T (hs-TNT) was measured. Mean and standard deviation were reported.
Time Frame
Baseline, Week 20
Title
Number of Participants With Composite Efficacy Outcome
Description
Composite efficacy outcome was the first occurrence of CV death, HF hospitalization or urgent visit for HF. Number of participants with composite efficacy outcome were reported.
Time Frame
Baseline up to Week 26
Title
Number of Participants With Cardiovascular (CV) Mortality
Description
Cardiovascular (CV) mortality was assessed. Number of participants with CV mortality were reported.
Time Frame
Baseline up to Week 26
Title
Number of Participants With Heart Failure (HF) Hospitalization and Urgent Visits for Heart Failure (HF)
Description
Number of participants with HF hospitalization and urgent visits for HF were reported.
Time Frame
Baseline up to Week 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men or women aged 18 years and older Diagnosis of chronic heart failure (CHF), NYHA ( New York Heart Association ) class II-IV, LVEF ≤ 35% and elevated NT-proBNP Exclusion Criteria: Acute de-novo heart failure Requirement of any intravenous (IV) treatments following 48 hours prior to randomization Mechanical support (e.g. intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, or any ventricular assist device) Any cause of chronic heart failure other than ischemic cardiomyopathy and idiopathic dilated cardiomyopathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
Facility Name
Southwest Florida Research
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
St. Louis Heart & Vascular, PC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63136
Country
United States
Facility Name
Glacier View Research Institute-Cardiology
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
St. Elizabeth Youngstown Hospital
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44501
Country
United States
Facility Name
Tennessee Center for Clinical Trials
City
Tullahoma
State/Province
Tennessee
ZIP/Postal Code
37388
Country
United States
Facility Name
East Texas Cardiology
City
Houston
State/Province
Texas
ZIP/Postal Code
77002
Country
United States
Facility Name
AZ St-Jan Brugge Oostende AV
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Grand Hôpital de Charleroi
City
Gilly
ZIP/Postal Code
6060
Country
Belgium
Facility Name
AZ Delta
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
AZ Turnhout
City
Turnhout
ZIP/Postal Code
2300
Country
Belgium
Facility Name
Spec Hosp for Active Treatm in Cardiology Sv Georgi Pernik
City
Pernik
ZIP/Postal Code
2300
Country
Bulgaria
Facility Name
Specialized Hospital for Actrive Treatm of Card - Pleven
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
NMTH Tzar Boris III
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
Facility Name
UMHAT Tsaritsa Joanna-ISUL EAD Sofia
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment Sveta Sofia
City
Sofia
ZIP/Postal Code
1618
Country
Bulgaria
Facility Name
MHAT Dr Stefan Cherkezov
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
Facility Name
Medizinische Hochschule Hannover (MHH)
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Facility Name
Herz- und Diabeteszentrum Nordrhein-Westfalen (HDZ NRW)
City
Bad Oeynhausen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
32545
Country
Germany
Facility Name
St.-Johannes-Hospital Dortmund
City
Dortmund
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44137
Country
Germany
Facility Name
Kliniken Maria Hilf GmbH
City
Mönchengladbach
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
41063
Country
Germany
Facility Name
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
City
Ludwigshafen
State/Province
Rheinland-Pfalz
ZIP/Postal Code
67063
Country
Germany
Facility Name
Charité Campus Virchow-Klinikum (CVK)
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
KAT General Hospital of Athens
City
Kifisia / Athens
State/Province
Attica
ZIP/Postal Code
14561
Country
Greece
Facility Name
G. Gennimatas General State Hospital of Athens
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Thriassio General Hospital of Elefsina
City
Elefsina
ZIP/Postal Code
19018
Country
Greece
Facility Name
Konstantopoulio General Hospital of Nea Ionia - Agia Olga
City
Nea Ionia / Athens
ZIP/Postal Code
142 33
Country
Greece
Facility Name
Hippokration General Hospital of Thessaloniki
City
Thessaloniki
ZIP/Postal Code
54642
Country
Greece
Facility Name
Barzilai Medical Center
City
Ashkelon
ZIP/Postal Code
7830604
Country
Israel
Facility Name
Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
3810101
Country
Israel
Facility Name
Rambam Health Corporation
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Facility Name
Hadassah University Hospital Mount Scopus
City
Jerusalem
Country
Israel
Facility Name
Tel-Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Assaf Harofeh Medical Center
City
Zrifin
ZIP/Postal Code
6093000
Country
Israel
Facility Name
A.O.U. Policlinico Federico II Napoli
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Facility Name
ASST Papa Giovanni XXIII
City
Bergamo
State/Province
Lombardia
ZIP/Postal Code
24127
Country
Italy
Facility Name
ASST Spedali Civili di Brescia
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25123
Country
Italy
Facility Name
IRCCS Centro Cardiologico Fondazione Monzino
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20138
Country
Italy
Facility Name
AUSL 8 Arezzo
City
Arezzo
State/Province
Toscana
ZIP/Postal Code
52040
Country
Italy
Facility Name
Gunma University Hospital
City
Maebashi
State/Province
Gunma
ZIP/Postal Code
371-8511
Country
Japan
Facility Name
National Hospital Organization Takasaki General Medical C
City
Takasaki
State/Province
Gunma
ZIP/Postal Code
370-0829
Country
Japan
Facility Name
Hyogo Prefectural Amagasaki General Medical Center
City
Amagasaki
State/Province
Hyogo
ZIP/Postal Code
660-8550
Country
Japan
Facility Name
National hospital Organization Mito Medical Center
City
Higashiibaraki
State/Province
Ibaraki
ZIP/Postal Code
311-3193
Country
Japan
Facility Name
R.I.A.C Naha City Hospital
City
Naha
State/Province
Okinawa
ZIP/Postal Code
902-8511
Country
Japan
Facility Name
Kishiwada Tokushukai Hospital
City
Kishiwada
State/Province
Osaka
ZIP/Postal Code
596-8522
Country
Japan
Facility Name
Takatsuki Red Cross Hospital
City
Takatsuki
State/Province
Osaka
ZIP/Postal Code
569-1096
Country
Japan
Facility Name
Minamino Cardiovascular Hospital
City
Hachioji
State/Province
Tokyo
ZIP/Postal Code
192-0918
Country
Japan
Facility Name
Nihon University Itabashi Hospital
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
173-8610
Country
Japan
Facility Name
Tokyo Women's Medical University Hospital
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
Facility Name
Hiroshima University Hospital
City
Hiroshima
ZIP/Postal Code
734-8511
Country
Japan
Facility Name
Okayama Rosai Hospital
City
Okayama
ZIP/Postal Code
702-8055
Country
Japan
Facility Name
Osaka General Medical Center
City
Osaka
ZIP/Postal Code
558-8558
Country
Japan
Facility Name
Toyama Prefectural Central Hospital
City
Toyama
ZIP/Postal Code
930-8550
Country
Japan
Facility Name
Onze Lieve Vrouwe Gasthuis
City
Amsterdam
ZIP/Postal Code
1091 AC
Country
Netherlands
Facility Name
Ziekenhuis Rijnstate
City
Arnhem
ZIP/Postal Code
6815 AD
Country
Netherlands
Facility Name
Universitair Medisch Centrum Groningen
City
Groningen
ZIP/Postal Code
9700 RB
Country
Netherlands
Facility Name
Erasmus Medisch Centrum
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
Facility Name
KLIMED Marek Klimkiewicz
City
Bialystok
ZIP/Postal Code
15-776
Country
Poland
Facility Name
CLINICAL MEDICAL RESEARCH Sp. z o. o.
City
Katowice
ZIP/Postal Code
40-156
Country
Poland
Facility Name
Szpital Specjalistyczny im. J. Dietla
City
Krakow
ZIP/Postal Code
31-121
Country
Poland
Facility Name
Nzoz Salus
City
Lodz
ZIP/Postal Code
91-302
Country
Poland
Facility Name
Szpital Kliniczny Przemienienia Panskiego
City
Poznan
ZIP/Postal Code
61-848
Country
Poland
Facility Name
Twoja Przychodnia - Szczecinskie Centrum Medyczne
City
Szczecin
ZIP/Postal Code
71-434
Country
Poland
Facility Name
IV Wojskowy Szpital Kliniczny z Poliklinika, SPZOZ
City
Wroclaw
ZIP/Postal Code
50-981
Country
Poland
Facility Name
Hospital Clínico Universitario de Santiago de Compostela
City
Santiago de Compostela
State/Province
A Coruña
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital Universitario "Virgen de la Arrixaca"
City
El Palmar
State/Province
Murcia
ZIP/Postal Code
30120
Country
Spain
Facility Name
Complejo Hospitalario Universitario A Coruña
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Clínico Universitario San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Clínico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Universitari i Politècnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
31523892
Citation
Voors AA, Bax JJ, Hernandez AF, Wirtz AB, Pap AF, Ferreira AC, Senni M, van der Laan M, Butler J; PANTHEON Investigators. Safety and efficacy of the partial adenosine A1 receptor agonist neladenoson bialanate in patients with chronic heart failure with reduced ejection fraction: a phase IIb, randomized, double-blind, placebo-controlled trial. Eur J Heart Fail. 2019 Nov;21(11):1426-1433. doi: 10.1002/ejhf.1591. Epub 2019 Sep 16.
Results Reference
derived
Links:
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

Learn more about this trial

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

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