Forxiga Tablets Specific Clinical Experience Investigation for Elderly

Completed

• Conditions: Type 2 Diabetes Mellitus

• Registration Number: NCT02200627
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of the investigation is to confirm the following under the post-marketing actual use of Forxiga Tablets (hereinafter referred to as Forxiga) in elderly patients.

* Development of ADRs specified as Key Investigation Items and the risk factors

* Contributing factors possibly having an impact on the safety and efficacy

* Development of ADRs unexpected from the Precautions for use and ADRs under actual drug use

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-24
• Study First Submitted QC: 2014-07-24
• Study First Posted: 2014-07-25
• Study Start: 2014-09
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-21
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1724

Inclusion Criteria

Patients treated with Forxiga for the first time during three months after the launch due to type 2 diabetes mellitus, which is the indication of the drug, aged 65 or over at the time when Forxiga was started.

In addition, patients receiving the study drug of Forxiga before the launch should be included also.

Exclusion Criteria

N/A

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse event incidence	from baseline to 1 year

Trial Locations

Locations (1)

Research Site; 🇯🇵 Yamanashi, Japan