Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
94
Countries
1
Sites
4
Chronic heart failure
Key facts
- Sponsor
- Corteria Pharmaceuticals
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 22 Jan 2024 → ongoing
- Decision date (initial)
- 2024-01-19
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Chronic heart failure
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10008908 | Chronic heart failure | 10007541 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Corteria Pharmaceuticals
- Sponsor organisation
- Corteria Pharmaceuticals
- Address
- 128 Rue La Boetie
- City
- Paris
- Postcode
- 75008
- Country
- France
Scientific contact point
- Organisation
- Corteria Pharmaceuticals
- Contact name
- Chief Medical Officer - Francesca Lawson
Public contact point
- Organisation
- Corteria Pharmaceuticals
- Contact name
- Chief Medical Officer - Francesca Lawson
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 94 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Pharmaceutical Research Associates Group B.V.
Program Management, Van Swietenlaan 6, 9728 NZ, Groningen
Deventer Ziekenhuis
Cardiology, Nico Bolkesteinlaan 75, 7416 SE, Deventer
D & A Research B.V.
Cardiology, Hegedyk 9, 8601 ZR, Sneek
Stichting Viecuri Medisch Centrum voor Noord-Limburg
Cardiology, Tegelseweg 210, 5912 BL, Venlo
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2024-01-22 | 2024-01-29 |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-20 | Netherlands | Acceptable 2024-01-19
|
2024-01-19 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-02-02 | Netherlands | Acceptable 2024-01-19
|
2024-02-02 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-01 | Netherlands | Acceptable 2024-03-27
|
2024-03-27 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-05-09 | Netherlands | Acceptable 2024-06-05
|
2024-06-05 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-06-14 | Netherlands | Acceptable 2024-07-08
|
2024-07-08 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-08-07 | Netherlands | Acceptable 2024-08-15
|
2024-08-15 |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-03-05 | Netherlands | Acceptable 2025-03-12
|
2025-03-13 |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-07-15 | Netherlands | Acceptable 2025-07-30
|
2025-07-30 |
| 9 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-10-31 | Netherlands | Acceptable 2025-11-28
|
2025-11-28 |
| 10 | SUBSTANTIAL MODIFICATION | SM-8 | 2026-02-25 | Netherlands | Acceptable 2026-03-05
|
2026-03-05 |