Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
56
Countries
2
Sites
2
Moderate Renal Impairment
Key facts
- Sponsor
- AstraZeneca AB
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 27 Sep 2024 → 29 May 2025
- Decision date (initial)
- 2024-09-16
- 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
Moderate Renal Impairment
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 22.1 | LLT | 10009122 | Chronic renal impairment | 10038359 |
| 20.0 | LLT | 10019279 | Heart failure | 10007541 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AstraZeneca AB
- Sponsor organisation
- AstraZeneca AB
- Address
- -
- City
- Sodertalje
- Postcode
- 151 85
- Country
- Sweden
Scientific contact point
- Organisation
- AstraZeneca AB
- Contact name
- AstraZeneca Clinical Study Information Centre
Public contact point
- Organisation
- AstraZeneca AB
- Contact name
- AstraZeneca Clinical Study Information Centre
Locations
2 EU/EEA countries · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ended | 28 | 1 |
| Sweden | Ended | 28 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Medical Center Comac Medical Ltd.
Clinical Research Unit for Phase I, Ulitsa Urvich 13, Krasno Selo District, Sofia
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 |
|---|---|---|---|---|---|
| Bulgaria | 2024-09-27 | 2024-09-27 | 2025-04-03 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-10 | Sweden | Acceptable 2024-08-12
|
2024-09-10 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-24 | Sweden | Acceptable 2024-12-09
|
2024-12-09 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-02-20 | Sweden | Acceptable 2025-04-07
|
2025-04-07 |