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Forxiga (Dapagliflozin) Regulatory Postmarketing Surveillance

NCT02252224 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3123

Last updated 2020-03-16

No results posted yet for this study

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 Article 32, Paragraph 1 and Article 37, Paragraph 3 of Pharmaceutical Affairs Law. MFDS requires that at least 3,000 patients who can be evaluated for safety assessment should be collected within 6 years from 26 Nov 2013 to 25 Nov 2019.

Conditions

Sponsors & Collaborators

Principal Investigators

  • A Ri Kim · AstraZeneca Korea - Medical Affairs

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-23
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • South Korea

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02252224 on ClinicalTrials.gov