Forxiga Tablets Specific Clinical Experience Investigatio... | NCT02200627

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2014

Primary Completion Date

Apr 2016Actual

Completion Date

Apr 2016Actual

First Submitted Date

Jul 24, 2014

First Submission Date that Met QC Criteria

Jul 24, 2014

First Posted Date

Jul 25, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 21, 2017

Last Update Posted Date

Feb 23, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,724Actual

Measure	Description	Time Frame
Adverse event incidence		from baseline to 1 year

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Aichi			Japan
Research Site

Label	URL
CSR\_Synopsis	View source

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D003924	Diabetes Mellitus, Type 2
D003920	Diabetes Mellitus

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases