Clinical trial NCT04865406: Forxiga HF General Drug Use-Results Study
Official title: Forxiga Tablets General Drug Use-Results Study in Patients With HF
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2021-04-29
Enrollment: 1221
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic heart failure who use Forxiga for the first time.

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

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: frequency of adverse drug reactions (ADRs)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Research Site
city: Akita
country: Japan
facility: Research Site
city: Aomori
country: Japan
facility: Research Site
city: Chiba
country: Japan
facility: Research Site
city: Ehime
country: Japan
facility: Research Site
city: Fukui
country: Japan
facility: Research Site
city: Fukuoka
country: Japan
facility: Research Site
city: Fukushima
country: Japan
facility: Research Site
city: Gifu
country: Japan
facility: Research Site
city: Gunma
country: Japan
facility: Research Site
city: Hiroshima
country: Japan
facility: Research Site
city: Hokkaido
country: Japan
facility: Research Site
city: Hyogo
country: Japan
facility: Research Site
city: Ibaraki
country: Japan
facility: Research Site
city: Ishikawa
country: Japan
facility: Research Site
city: Iwate
country: Japan
facility: Research Site
city: Kagawa
country: Japan
facility: Research Site
city: Kagoshima
country: Japan
facility: Research Site
city: Kanagawa
country: Japan
facility: Research Site
city: Kochi
country: Japan
facility: Research Site
city: Kumamoto
country: Japan
facility: Research Site
city: Kyoto
country: Japan
facility: Research Site
city: Mie
country: Japan
facility: Research Site
city: Miyagi
country: Japan
facility: Research Site
city: Miyazaki
country: Japan
facility: Research Site
city: Nagano
country: Japan
facility: Research Site
city: Nagasaki
country: Japan
facility: Research Site
city: Nara
country: Japan
facility: Research Site
city: Oita
country: Japan
facility: Research Site
city: Okayama
country: Japan
facility: Research Site
city: Okinawa
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Saga
country: Japan
facility: Research Site
city: Saitama
country: Japan
facility: Research Site
city: Shiga
country: Japan
facility: Research Site
city: Shimane
country: Japan
facility: Research Site
city: Shizuoka
country: Japan
facility: Research Site
city: Tochigi
country: Japan
facility: Research Site
city: Tokushima
country: Japan
facility: Research Site
city: Tokyo
country: Japan
facility: Research Site
city: Toyama
country: Japan
facility: Research Site
city: Wakayama
country: Japan
facility: Research Site
city: Yamagata
country: Japan
facility: Research Site
city: Yamaguchi
country: Japan
facility: Research Site
city: Yamanashi
country: Japan
facility: Research Site
Study officials:
References: