Status:
COMPLETED
Forxiga (Dapagliflozin) Regulatory Postmarketing Surveillance
Lead Sponsor:
AstraZeneca
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
Brief Summary
This surveillance is a postmarketing commitment following the marketing authorization for Forxiga(dapagliflozin) in accordance with Standards on Re-examination of New Drugs, notified by the MFDS under...
Detailed Description
Protocol Title: Forxiga (dapagliflozin) Regulatory Postmarketing Surveillance Department: Korea Medical Objective(s): The primary objective of this study is to examine the safety profiles of Forxiga...
Eligibility Criteria
Inclusion
- Patients aged 18 years and older
- Patients with T2DM eligible for treatment with Forxiga as indicated in the locally approved prescribing information
- Patients with evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Exclusion
- Patients treated with Forxiga outside of the locally approved label in Korea
- Patients with contraindications for the use of Forxiga (as described in the Korean product label)
Key Trial Info
Start Date :
September 23 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 30 2016
Estimated Enrollment :
3123 Patients enrolled
Trial Details
Trial ID
NCT02252224
Start Date
September 23 2014
End Date
November 30 2016
Last Update
March 16 2020
Active Locations (6)
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1
Research Site
Bucheon-si, South Korea
2
Research Site
Busan, South Korea
3
Research Site
Daejeon, South Korea
4
Research Site
Jeonju, South Korea