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NCT04865406 Clinical Trial

Forxiga HF General Drug Use-Results Study

Heart Failure Clinical Trial

Official title:
Forxiga Tablets General Drug Use-Results Study in Patients With HF

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04865406
Other study ID # D1699C00017
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 10, 2021
Est. completion date March 31, 2024

Study information
Verified date January 2024
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To capture safety when Forxiga is administered to patients with HF in clinical practice after launch.

Description:

The purpose of the study is to review the following points during use of Forxiga Tablets (hereinafter referred to as Forxiga) in the real world setting after launch. 1. ADRs which are unexpected from the precautions for use 2. Understanding of incidence of ADRs during use of Forxiga in the real world setting 3. Factors possibly having an impact on the safety

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 1221
Est. completion date March 31, 2024
Est. primary completion date March 31, 2024
Accepts healthy volunteers No
Gender All
Age group 15 Years and older
Eligibility Inclusion Criteria: - Patients aged more than 15 years - Patients who have been prescribed Forxiga for the first time Exclusion Criteria: - Patients with a history of hypersensitivity to any ingredients of this drug. - Patients with severe ketosis, diabetic coma or precoma - Patients with severe infections, before or after a surgery, or with serious trauma

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Japan Research Site Aichi
Japan Research Site Akita
Japan Research Site Aomori
Japan Research Site Chiba
Japan Research Site Ehime
Japan Research Site Fukui
Japan Research Site Fukuoka
Japan Research Site Fukushima
Japan Research Site Gifu
Japan Research Site Gunma
Japan Research Site Hiroshima
Japan Research Site Hokkaido
Japan Research Site Hyogo
Japan Research Site Ibaraki
Japan Research Site Ishikawa
Japan Research Site Iwate
Japan Research Site Kagawa
Japan Research Site Kagoshima
Japan Research Site Kanagawa
Japan Research Site Kochi
Japan Research Site Kumamoto
Japan Research Site Kyoto
Japan Research Site Mie
Japan Research Site Miyagi
Japan Research Site Miyazaki
Japan Research Site Nagano
Japan Research Site Nagasaki
Japan Research Site Nara
Japan Research Site Niigata
Japan Research Site Oita
Japan Research Site Okayama
Japan Research Site Okinawa
Japan Research Site Osaka
Japan Research Site Saga
Japan Research Site Saitama
Japan Research Site Shiga
Japan Research Site Shimane
Japan Research Site Shizuoka
Japan Research Site Tochigi
Japan Research Site Tokushima
Japan Research Site Tokyo
Japan Research Site Toyama
Japan Research Site Wakayama
Japan Research Site Yamagata
Japan Research Site Yamaguchi
Japan Research Site Yamanashi

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary frequency of adverse drug reactions (ADRs) Development of ADRs by unexpected from "Precautions for Use" of Forxiga JPI, by SOC, by patient demography and by treatment 1 year
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