Overview
Sponsor-declared trial summary
Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.
Key facts
- Sponsor
- Celon Pharma S.A.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 20 Aug 2024 → 21 Oct 2024
- Decision date (initial)
- 2024-08-13
- 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
Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10051055 | Deep vein thrombosis | 100000004866 |
| 23.1 | LLT | 10084868 | Systemic embolism | 100000004848 |
| 20.0 | LLT | 10014521 | Embolism pulmonary | 10038738 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Celon Pharma S.A.
- Sponsor organisation
- Celon Pharma S.A.
- Address
- Ul. Ogrodowa 2a, Kielpin Kielpin
- City
- Lomianki
- Postcode
- 05-092
- Country
- Poland
Scientific contact point
- Organisation
- Celon Pharma S.A.
- Contact name
- Clinical trial information point
Public contact point
- Organisation
- Celon Pharma S.A.
- Contact name
- Clinical trial information point
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Ended | 38 | 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 | 2024-08-20 | 2024-10-21 | 2024-09-01 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-07 | Poland | Acceptable 2024-08-09
|
2024-08-13 |