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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence (%) of adverse events (AEs), serious AEs (SAEs), adverse drug reactions (ADRs), serious ADRs (SADRs), unexpected AEs/ADRs, unexpected SAEs, SADRs | 12weeks or 24weeks |
| Measure | Description | Time Frame |
|---|---|---|
| No worsening in NYHA class from baseline | 12 weeks or 24 weeks | |
| No worsening in UACR category from baseline | 12 weeks or 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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On active study drug treatment according to the approved local label.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Busan | 47392 | South Korea | |||
| Research Site |
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| Label | URL |
|---|---|
| D169900007\_Redacted\_CSR Synopsis | View source |
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Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.
All request will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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| Busan |
| 48108 |
| South Korea |
| Research Site | Busan | 49201 | South Korea |
| Research Site | Changwon | 51353 | South Korea |
| Research Site | Changwon | 51472 | South Korea |
| Research Site | Daegu | 41931 | South Korea |
| Research Site | Daegu | 42415 | South Korea |
| Research Site | Daejeon | 302-812 | South Korea |
| Research Site | Daejeon | 34134 | South Korea |
| Research Site | Daejeon | 35233 | South Korea |
| Research Site | Gwangju | 61469 | South Korea |
| Research Site | Iksan | 54538 | South Korea |
| Research Site | Jeonju | 54907 | South Korea |
| Research Site | Jeonju | 54987 | South Korea |
| Research Site | Seongnam-si | 13590 | South Korea |
| Research Site | Seoul | 02447 | South Korea |
| Research Site | Seoul | 02841 | South Korea |
| Research Site | Seoul | 158-710 | South Korea |
| Research Site | Seoul | 2447 | South Korea |
| Research Site | Seoul | 3080 | South Korea |
| Research Site | Seoul | 4763 | South Korea |
| Research Site | Seoul | 5355 | South Korea |
| Research Site | Seoul | 6591 | South Korea |
| Research Site | Suncheon | 57931 | South Korea |
| Research Site | Suwon | 16247 | South Korea |
| Research Site | Uijeongbu-si | 480-130 | South Korea |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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