Clinical trial • Phase I • Cardiology
COR-1167 for Chronic heart failure
Phase I trial of COR-1167 for Chronic heart failure. Randomised, placebo-controlled, adaptive. 94 participants.
Overview
- Trial Therapeutic Area
- Cardiology
- Trial Disease
- Chronic heart failure
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 20-11-2023
- First CTIS Authorization Date
- 19-01-2024
Trial design
Randomised, placebo-controlled, adaptive Phase I trial across 4 sites in Netherlands.
- Randomised
- Yes
- Comparator
- Placebo
- Adaptive
- Yes
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 94
Eligibility
Recruits 94 No vulnerable populations selected; consent/assent handling not specified..
- Vulnerable Population
- No vulnerable populations selected; consent/assent handling not specified.
Recruitment
- Planned Sample Size
- 94
- Recruitment Window Months
- 29
Geography
- Total Number Of Sites
- 4
- Total Number Of Participants
- 94
Netherlands
- Earliest CTIS Part Ii Submission Date
- 11-01-2024
- Latest Decision Or Authorization Date
- 28-11-2025
- Processing Time Days
- 687
- Number Of Sites
- 4
- Number Of Participants
- 94
Sites
- Site Name
- Pharmaceutical Research Associates Group B.V.
- Department Name
- Program Management
- Contact Person Name
- Jan Leendert Brouwer
- Contact Person Email
- janleendert.brouwer@iconplc.com
- Site Name
- D & A Research B.V.
- Department Name
- Cardiology
- Contact Person Name
- Henk Swart
- Contact Person Email
- h.swart@mijnantonius.nl
- Site Name
- Deventer Ziekenhuis
- Department Name
- Cardiology
- Contact Person Name
- Wouter Jansen Klomp
- Contact Person Email
- jansenklomp@dz.nl
- Site Name
- Stichting Viecuri Medisch Centrum voor Noord-Limburg
- Department Name
- Cardiology
- Contact Person Name
- Wouter Remkes
- Contact Person Email
- wremkes@viecuri.nl
Sponsor
Primary sponsor
- Full Name
- Corteria Pharmaceuticals
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- France
Contract research organisations
- Name
- Pharmaceutical Research Associates Group B.V.
- Responsibilities
- Program Management; contact: janleendert.brouwer@iconplc.com
Investigational products
- Investigational Product Name
- COR-1167
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