Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
106
Countries
1
Sites
1
Heart failure (HF)
Key facts
- Sponsor
- Novartis Pharma AG
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 30 Nov 2023 → 24 Nov 2025
- Decision date (initial)
- 2023-11-20
- 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
Heart failure (HF)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10007648 | Cardiovascular disease unspecified | 10007541 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Novartis Pharma AG
- Sponsor organisation
- Novartis Pharma AG
- Address
- Lichtstrasse 35
- City
- Basel Town
- Postcode
- 4056
- Country
- Switzerland
Scientific contact point
- Organisation
- Novartis Pharma AG
- Contact name
- Novartis Pharma Arzneimittel GmbH
Public contact point
- Organisation
- Novartis Pharma AG
- Contact name
- Novartis Pharma Arzneimittel GmbH
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 106 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Pharmaceutical Research Associates Group B.V.
Program Management, Van Swietenlaan 6, 9728 NZ, Groningen
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 | 2023-11-30 | 2025-11-24 | 2023-11-30 | 2025-11-03 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-25 | Netherlands | Acceptable 2023-11-20
|
2023-11-20 |
| 2 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-12-12 | Netherlands | Acceptable 2024-12-20
|
2024-12-20 |
| 3 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-03-25 | Netherlands | Acceptable | 2025-04-28 |
| 4 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-10-29 | Netherlands | Acceptable 2025-11-05
|
2025-11-05 |