Clinical trial • Phase III • Cardiology
Nurandociguat for Chronic kidney disease | Arterial hypertension
Phase III trial of Nurandociguat for Chronic kidney disease | Arterial hypertension. 36 participants.
Overview
- Trial Therapeutic Area
- Cardiology
- Trial Disease
- Chronic kidney disease | Arterial hypertension
- Trial Stage
- Phase III
- Drug Modality
- Small molecule|Small molecule
Key dates
- Initial CTIS Submission Date
- 26-09-2025
- First CTIS Authorization Date
- 12-11-2025
Trial design
Phase III trial across 2 sites in Germany.
- Target Sample Size
- 36
Eligibility
Recruits 36 No vulnerable populations selected; trial population restricted to male subjects; consent/assent handling not specified in provided data..
- Vulnerable Population
- No vulnerable populations selected; trial population restricted to male subjects; consent/assent handling not specified in provided data.
Recruitment
- Planned Sample Size
- 36
- Recruitment Window Months
- 4
- Consent Approach
- Informed consent process not specified in provided data.
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 36
Germany
- Earliest CTIS Part Ii Submission Date
- 05-11-2025
- Latest Decision Or Authorization Date
- 11-03-2026
- Processing Time Days
- 126
- Number Of Sites
- 2
- Number Of Participants
- 36
Sites
- Site Name
- CRS Clinical Research Services Mannheim GmbH
- Contact Person Name
- Edis Gasanin
- Contact Person Email
- edis.gasanin@crs-group.de
- Site Name
- CRS Clinical Research Services Berlin GmbH
- Contact Person Name
- Matthias Berse
- Contact Person Email
- matthias.berse@crs-group.de
Sponsor
Primary sponsor
- Full Name
- Bayer AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Contract research organisations
- Name
- CRS Clinical Research Services Mannheim GmbH
- Responsibilities
- Local trial site conduct and trial management (site listed in CTIS trial sites)
- Name
- CRS Clinical Research Services Berlin GmbH
- Responsibilities
- Local trial site conduct and trial management (site listed in CTIS trial sites)
Investigational products
- Investigational Product Name
- Nurandociguat
- Active Substance
- Nurandociguat
- Modality
- Small molecule
- Investigational Product Name
- Sildenafil
- Active Substance
- Sildenafil
- Modality
- Small molecule
- Combination Treatment
- Yes
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