Dapagliflozin Post Marketing Surveillance in HF and CKD
Dapagliflozin Post-Marketing Surveillance in Heart Failure Patients and Chronic Kidney Disease Patients
1 other identifier
observational
815
1 country
26
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2022
Typical duration for all trials
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 15, 2021
CompletedFirst Posted
Study publicly available on registry
November 26, 2021
CompletedStudy Start
First participant enrolled
March 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 20, 2024
CompletedJanuary 13, 2025
January 1, 2025
2.2 years
November 15, 2021
January 10, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence (%) of adverse events (AEs), serious AEs (SAEs), adverse drug reactions (ADRs), serious ADRs (SADRs), unexpected AEs/ADRs, unexpected SAEs, SADRs
12weeks or 24weeks
Secondary Outcomes (2)
No worsening in NYHA class from baseline
12 weeks or 24 weeks
No worsening in UACR category from baseline
12 weeks or 24 weeks
Eligibility Criteria
On active study drug treatment according to the approved local label.
You may qualify if:
- 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
You may not qualify if:
- Participation in any interventional trial during the treatment with the product.
- 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).
- Prior use of product, as per local MFDS guidance.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (26)
Research Site
Busan, 47392, South Korea
Research Site
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
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 15, 2021
First Posted
November 26, 2021
Study Start
March 10, 2022
Primary Completion
May 20, 2024
Study Completion
May 20, 2024
Last Updated
January 13, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- 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.
- Access Criteria
- 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.
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.