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
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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