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Completed

NCT Number: NCT04865406

Forxiga HF General Drug Use-Results Study

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

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Aichi, Japan

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About this study

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.

  • ADRs which are unexpected from the precautions for use
  • Understanding of incidence of ADRs during use of Forxiga in the real world setting
  • Factors possibly having an impact on the safety

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. frequency of adverse drug reactions (ADRs)

    Time frame: 1 year

    Development of ADRs by unexpected from "Precautions for Use" of Forxiga JPI, by SOC, by patient demography and by treatment

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 29, 2021
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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