Clinical trial • Phase III • Cardiology

nitroglycerin for Chronic kidney disease | Coronary artery disease

Phase III trial of nitroglycerin for Chronic kidney disease | Coronary artery disease. 36 participants.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Chronic kidney disease | Coronary artery disease
Trial Stage
Phase III
Drug Modality
Small molecule | Small molecule

Key dates

Initial CTIS Submission Date
08-10-2025
First CTIS Authorization Date
22-01-2026

Trial design

Phase III trial in Germany, Bulgaria.

Target Sample Size
36

Eligibility

Recruits 36 No vulnerable populations selected (isVulnerablePopulationSelected: false).

Vulnerable Population
No vulnerable populations selected (isVulnerablePopulationSelected: false)

Recruitment

Planned Sample Size
36
Recruitment Window Months
7

Geography

Total Number Of Sites
6
Total Number Of Participants
36

Germany

Earliest CTIS Part Ii Submission Date
08-01-2026
Latest Decision Or Authorization Date
12-02-2026
Processing Time Days
35
Number Of Sites
4
Number Of Participants
26

Sites

Site Name
Universitaetsklinikum Bonn AöR
Department Name
Phase I Einheit und Arzneimitteltherapiesicherheit
Principal Investigator Name
Martin Coenen
Principal Investigator Email
martin.coenen@ukbonn.de
Contact Person Name
Martin Coenen
Contact Person Email
martin.coenen@ukbonn.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Kardiologie, Angiologie und Intensivmedizin CVK
Principal Investigator Name
Frank Edelmann
Principal Investigator Email
frank.edelmann@dhzc-charite.de
Contact Person Name
Frank Edelmann
Contact Person Email
frank.edelmann@dhzc-charite.de
Site Name
SocraTec R&D Concepts in Drug Research and Development GmbH
Department Name
Clinical Pharmacology Unit
Principal Investigator Name
Victoria Reich
Principal Investigator Email
victoria.reich@socratec-pharma.de
Contact Person Name
Victoria Reich
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Klinische Pharmakologie und Pharmakoepidemologie
Principal Investigator Name
Antje Blank
Principal Investigator Email
antje.blank@med.uni-heidelberg.de
Contact Person Name
Antje Blank

Bulgaria

Earliest CTIS Part Ii Submission Date
02-02-2026
Latest Decision Or Authorization Date
03-04-2026
Processing Time Days
60
Number Of Sites
2
Number Of Participants
10

Sites

Site Name
Medical Center Comac Medical Ltd.
Principal Investigator Name
Tsvetan Kotsev
Principal Investigator Email
tsvetan.kotsev@comac-medical.com
Contact Person Name
Tsvetan Kotsev
Site Name
Medical Center Comac Medical Ltd.
Principal Investigator Name
Tsvetan Kotsev
Principal Investigator Email
tsvetan.kotsev@comac-medical.com
Contact Person Name
Tsvetan Kotsev

Sponsor

Primary sponsor

Full Name
Bayer AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Investigational products

Investigational Product Name
Nitroglycerin
Active Substance
nitroglycerin
Modality
Small molecule
Investigational Product Name
Nurandociguat
Active Substance
nurandociguat
Modality
Small molecule
Combination Treatment
Yes

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