Forxiga HF General Drug Use-Results Study

Sponsor
AstraZeneca (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04865406
Collaborator
(none)
1,200
Enrollment
76
Locations
34.7
Anticipated Duration (Months)
15.8
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or DiseaseIntervention/TreatmentPhase

    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

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Forxiga Tablets General Drug Use-Results Study in Patients With HF
    Actual Study Start Date :
    May 10, 2021
    Anticipated Primary Completion Date :
    Mar 31, 2024
    Anticipated Study Completion Date :
    Mar 31, 2024

    Outcome Measures

    Primary Outcome Measures

    1. frequency of adverse drug reactions (ADRs) [1 year]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Research SiteAichiJapan
    2Research SiteAichiJapan
    3Research SiteAkitaJapan
    4Research SiteAomoriJapan
    5Research SiteAomoriJapan
    6Research SiteChibaJapan
    7Research SiteChibaJapan
    8Research SiteEhimeJapan
    9Research SiteEhimeJapan
    10Research SiteFukuiJapan
    11Research SiteFukuokaJapan
    12Research SiteFukushimaJapan
    13Research SiteGifuJapan
    14Research SiteGunmaJapan
    15Research SiteHiroshimaJapan
    16Research SiteHiroshimaJapan
    17Research SiteHiroshimaJapan
    18Research SiteHokkaidoJapan
    19Research SiteHokkaidoJapan
    20Research SiteHyogoJapan
    21Research SiteHyogoJapan
    22Research SiteHyogoJapan
    23Research SiteHyogoJapan
    24Research SiteIbarakiJapan
    25Research SiteIbarakiJapan
    26Research SiteIshikawaJapan
    27Research SiteIwateJapan
    28Research SiteIwateJapan
    29Research SiteKagawaJapan
    30Research SiteKagoshimaJapan
    31Research SiteKanagawaJapan
    32Research SiteKanagawaJapan
    33Research SiteKanagawaJapan
    34Research SiteKochiJapan
    35Research SiteKumamotoJapan
    36Research SiteKyotoJapan
    37Research SiteKyotoJapan
    38Research SiteMieJapan
    39Research SiteMieJapan
    40Research SiteMiyagiJapan
    41Research SiteMiyazakiJapan
    42Research SiteNaganoJapan
    43Research SiteNaganoJapan
    44Research SiteNagasakiJapan
    45Research SiteNaraJapan
    46Research SiteNiigataJapan
    47Research SiteNiigataJapan
    48Research SiteOitaJapan
    49Research SiteOitaJapan
    50Research SiteOkayamaJapan
    51Research SiteOkinawaJapan
    52Research SiteOkinawaJapan
    53Research SiteOsakaJapan
    54Research SiteOsakaJapan
    55Research SiteOsakaJapan
    56Research SiteSagaJapan
    57Research SiteSagaJapan
    58Research SiteSaitamaJapan
    59Research SiteSaitamaJapan
    60Research SiteSaitamaJapan
    61Research SiteShigaJapan
    62Research SiteShimaneJapan
    63Research SiteShimaneJapan
    64Research SiteShizuokaJapan
    65Research SiteShizuokaJapan
    66Research SiteTochigiJapan
    67Research SiteTokushimaJapan
    68Research SiteTokushimaJapan
    69Research SiteTokyoJapan
    70Research SiteTokyoJapan
    71Research SiteToyamaJapan
    72Research SiteWakayamaJapan
    73Research SiteYamagataJapan
    74Research SiteYamaguchiJapan
    75Research SiteYamaguchiJapan
    76Research SiteYamanashiJapan

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT04865406
    Other Study ID Numbers:
    • D1699C00017
    First Posted:
    Apr 29, 2021
    Last Update Posted:
    Oct 7, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 7, 2021