Study identifier:D1699R00007
ClinicalTrials.gov identifier:NCT05134701
EudraCT identifier:N/A
CTIS identifier:N/A
Dapagliflozin Post-Marketing Surveillance in Heart Failure Patients and Chronic Kidney Disease Patients
heart failure
N/A
No
-
All
815
Observational
19 Years - n/a
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verified 01 Jan 2025 by AstraZeneca
AstraZeneca
-
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
As part of a post-approval commitment, the Ministry of Food and Drug Safety (MFDS) of the Republic of Korea (hereinafter “Korea”) requests a study to characterize the safety in patients treated with dapagliflozin by physicians in normal clinical practice settings. In principle, all patients treated with the product in accordance with the newly updated local prescribing information for HF and/or CKD are eligible for the enrolment in this study. Product prescription and patient enrollment will depend on physicians’ medical decision as per routine clinical practice. Patient follow-up will be 12 weeks or about 24 weeks (for long-term surveillance) and patients will be recruited over a period of 4 years after the new HFrEF indication approval by the local health authorities. This is due to the requirements from the local health authorities. The primary objective of this study is to assess the safety profile of the product in Korean adult patients with heart failure (HF) and/or chronic kidney disease (CKD) in a real world setting under the approved indication(s) in Korea. The secondary objective of this study is to examine the effectiveness of the product in Korean patients with 1) HF and/or 2) CKD in a real world setting under the approved indication(s) in Korea. The exploratory objective of this study is to identify patients’ baseline characteristics that might be associated with the safety and effectiveness of the product when prescribed under the newly approved indication(s) in Korean patients with 1) HF and/or 2) CKD during the 12 weeks or about 24 weeks of follow-up duration.
Location
Location
Gwangju, South Korea, Republic of Korea, 61469
Location
Daejeon-si, South Korea, Republic of Korea, 35233
Location
Jeonju, South Korea, Republic of Korea, 54907
Location
Jeonju, South Korea, Republic of Korea, 54987
Location
Uijeongbu-si, South Korea, Republic of Korea, 480-130
Location
Busan, South Korea, Republic of Korea, 47392
Location
Busan, South Korea, Republic of Korea, 48108
Location
Seoul, South Korea, Republic of Korea, 158-710
Arms | Assigned Interventions |
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