Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
10
Countries
1
Sites
1
ventricular failure caused by ischemic heart disease
Key facts
- Sponsor
- Viscofan Espana S.L.U.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- completed 1 Oct 2025
- Decision date (initial)
- 2024-11-05
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517738-16-00
- EudraCT number
- 2022-002180-29
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
ventricular failure caused by ischemic heart disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 25.1 | PT | 10070589 | Ischaemic contracture of the left ventricle | 100000004863 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Viscofan Espana S.L.U.
- Sponsor organisation
- Viscofan Espana S.L.U.
- Address
- Berroa Kalea 15 Piso 4, Tajonar Tajonar
- City
- Aranguren
- Postcode
- 31192
- Country
- Spain
Scientific contact point
- Organisation
- Viscofan Espana S.L.U.
- Contact name
- Lluis Quintana Frigola
Public contact point
- Organisation
- Viscofan Espana S.L.U.
- Contact name
- Lluis Quintana Frigola
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Ended | 10 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Poland |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-16 | Poland | Acceptable 2024-10-31
|
2024-11-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-03-12 | Poland | Acceptable | 2025-04-24 |