Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ongoing, recruiting
Participants planned
6
Countries
1
Sites
1
heart failure
Key facts
- Sponsor
- UZ Brussel
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 17 Jan 2024 → ongoing
- Decision date (initial)
- 2024-09-12
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-514318-11-00
- EudraCT number
- 2022-002628-11
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
heart failure
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10016163 | Failure right heart | 10007541 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
UZ Brussel
- Sponsor organisation
- UZ Brussel
- Address
- Laarbeeklaan 101
- City
- Jette
- Postcode
- 1090
- Country
- Belgium
Scientific contact point
- Organisation
- UZ Brussel
- Contact name
- Matthias Raes
Public contact point
- Organisation
- UZ Brussel
- Contact name
- Van Malderen Claire
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 6 | 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 |
|---|---|---|---|---|---|
| Belgium | 2024-01-17 | 2024-05-15 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-10 | Belgium | Acceptable with conditions 2024-09-11
|
2024-09-12 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-01-26 | Belgium | Acceptable with conditions 2024-09-11
|
2026-01-26 |