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Forxiga HF General Drug Use-Results Study

Sponsor
AstraZeneca (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04865406
Collaborator
(none)
1,200
Enrollment
102
Locations
34.7
Anticipated Duration (Months)
11.8
Patients Per Site
0.3
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 Disease Intervention/Treatment Phase

    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

    Site City State Country Postal Code
    1 Research Site Aichi Japan
    2 Research Site Aichi Japan
    3 Research Site Aichi Japan
    4 Research Site Aichi Japan
    5 Research Site Akita Japan
    6 Research Site Aomori Japan
    7 Research Site Aomori Japan
    8 Research Site Chiba Japan
    9 Research Site Chiba Japan
    10 Research Site Chiba Japan
    11 Research Site Ehime Japan
    12 Research Site Ehime Japan
    13 Research Site Fukui Japan
    14 Research Site Fukuoka Japan
    15 Research Site Fukuoka Japan
    16 Research Site Fukuoka Japan
    17 Research Site Fukushima Japan
    18 Research Site Fukushima Japan
    19 Research Site Gifu Japan
    20 Research Site Gifu Japan
    21 Research Site Gunma Japan
    22 Research Site Gunma Japan
    23 Research Site Gunma Japan
    24 Research Site Hiroshima Japan
    25 Research Site Hiroshima Japan
    26 Research Site Hiroshima Japan
    27 Research Site Hokkaido Japan
    28 Research Site Hokkaido Japan
    29 Research Site Hyogo Japan
    30 Research Site Hyogo Japan
    31 Research Site Hyogo Japan
    32 Research Site Ibaraki Japan
    33 Research Site Ibaraki Japan
    34 Research Site Ishikawa Japan
    35 Research Site Iwate Japan
    36 Research Site Kagawa Japan
    37 Research Site Kagawa Japan
    38 Research Site Kagoshima Japan
    39 Research Site Kagoshima Japan
    40 Research Site Kagoshima Japan
    41 Research Site Kanagawa Japan
    42 Research Site Kanagawa Japan
    43 Research Site Kanagawa Japan
    44 Research Site Kanagawa Japan
    45 Research Site Kanagawa Japan
    46 Research Site Kochi Japan
    47 Research Site Kochi Japan
    48 Research Site Kochi Japan
    49 Research Site Kumamoto Japan
    50 Research Site Kumamoto Japan
    51 Research Site Kyoto Japan
    52 Research Site Kyoto Japan
    53 Research Site Mie Japan
    54 Research Site Mie Japan
    55 Research Site Miyagi Japan
    56 Research Site Miyagi Japan
    57 Research Site Miyazaki Japan
    58 Research Site Miyazaki Japan
    59 Research Site Nagano Japan
    60 Research Site Nagasaki Japan
    61 Research Site Nagasaki Japan
    62 Research Site Nara Japan
    63 Research Site Nara Japan
    64 Research Site Niigata Japan
    65 Research Site Niigata Japan
    66 Research Site Oita Japan
    67 Research Site Oita Japan
    68 Research Site Okayama Japan
    69 Research Site Okayama Japan
    70 Research Site Okinawa Japan
    71 Research Site Okinawa Japan
    72 Research Site Osaka Japan
    73 Research Site Osaka Japan
    74 Research Site Osaka Japan
    75 Research Site Saga Japan
    76 Research Site Saga Japan
    77 Research Site Saga Japan
    78 Research Site Saitama Japan
    79 Research Site Saitama Japan
    80 Research Site Shiga Japan
    81 Research Site Shiga Japan
    82 Research Site Shimane Japan
    83 Research Site Shizuoka Japan
    84 Research Site Shizuoka Japan
    85 Research Site Shizuoka Japan
    86 Research Site Tochigi Japan
    87 Research Site Tochigi Japan
    88 Research Site Tokushima Japan
    89 Research Site Tokushima Japan
    90 Research Site Tokyo Japan
    91 Research Site Tokyo Japan
    92 Research Site Tokyo Japan
    93 Research Site Toyama Japan
    94 Research Site Toyama Japan
    95 Research Site Wakayama Japan
    96 Research Site Wakayama Japan
    97 Research Site Yamagata Japan
    98 Research Site Yamagata Japan
    99 Research Site Yamaguchi Japan
    100 Research Site Yamaguchi Japan
    101 Research Site Yamanashi Japan
    102 Research Site Yamanashi Japan

    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:
    Aug 3, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Aug 3, 2022