Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
25
Countries
1
Sites
5
Recurrent Pericarditis
Key facts
- Sponsor
- Cardiol Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- completed 6 Sep 2024
- Decision date (initial)
- 2024-01-05
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-507452-77-00
- ClinicalTrials.gov
- NCT05494788
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Recurrent Pericarditis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10034484 | Pericarditis | 100000004849 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Cardiol Therapeutics Inc.
- Sponsor organisation
- Cardiol Therapeutics Inc.
- Address
- 2265 Upper Middle Rd E Suite 602
- City
- Oakville
- Postcode
- L6H 0G5
- Country
- Canada
Scientific contact point
- Organisation
- Cardiol Therapeutics Inc.
- Contact name
- corporate inquiries
Public contact point
- Organisation
- Cardiol Therapeutics Inc.
- Contact name
- corporate inquiries
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 10 | 5 |
| Rest of world
United States
|
— | 15 | — |
Investigational sites
Assistance Publique Hopitaux De Paris
Cardiologie, 20 Rue Leblanc, 75015, Paris
Centre Hospitalier Universitaire De Caen Normandie
Cardiologie, Avenue De La Cote De Nacre, Cs 30001, Caen Cedex 9
Hopital Universitaire Pitie Salpetriere
Cardiologie, 47 Boulevard De L Hopital, 75651, Paris Cedex 13
Centre Hospitalier Universitaire De Poitiers
Cardiologie, 2 Rue De La Miletrie, 86000, Poitiers
Assistance Publique Hopitaux De Paris
Cardiologie, 46 Rue Henri Huchard, 75877, Paris Cedex 18
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-29 | France | Acceptable 2023-12-19
|
2024-01-05 |