NCT05134701Completed
Dapagliflozin Post Marketing Surveillance in HF and CKD
Dapagliflozin Post-Marketing Surveillance in Heart Failure Patients and Chronic Kidney Disease Patients
Source: ClinicalTrials.gov · Last updated 13 Jan 2025
Brief summary (registry, in English)
This is an observational, non-interventional, single-arm multicenter study. The objectives of this study are to assess safety and effectiveness of Forxiga in a real world setting in patients who are prescribed with the study drug according to the newly approved indications in the Republic of Korea
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 815 (actual)
- First submitted
- 15 Nov 2021
- Start date
- 10 Mar 2022
- Primary completion date
- 20 May 2024
- Lead sponsor
- AstraZeneca
- Diseases
- Chronic kidney disease, Heart failure
- NCT number
- NCT05134701
What you commit to
- Study type: Observational
- Participants enrolled: 815
- From 10 Mar 2022 to the primary completion date, 20 May 2024
- 12 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in any interventional trial during the treatment with the product.
- Prior use of product, as per local MFDS guidance.
Other
- Any off-label indications that are not in accordance with the newly approved label in Korea.
- Any contraindications for the use of the product (as described in the local prescribing information).
Who the study is looking for
- Patients aged 19 years old and older
- Patients eligible for the product treatment (i.e. on-label treatment) according to the newly approved HF and/or CKD label in Korea
- Provision of signed and dated written informed consent by the patient or legally acceptable representative
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| - Coordinator of this site? Confirm its status | Changwon | South Korea | Unknown status |
| - Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| - Coordinator of this site? Confirm its status | Daejeon | South Korea | Unknown status |
| - Coordinator of this site? Confirm its status | Gwangju | South Korea | Unknown status |
| - Coordinator of this site? Confirm its status | Iksan | South Korea | Unknown status |
| - Coordinator of this site? Confirm its status | Jeonju | South Korea | Unknown status |
| - Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Unknown status |
| - Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| - Coordinator of this site? Confirm its status | Suncheon | South Korea | Unknown status |
| - Coordinator of this site? Confirm its status | Suwon | South Korea | Unknown status |
| - Coordinator of this site? Confirm its status | Uijeongbu-si | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.