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Post Marketing Surveillance (PMS) of JARDIANCE in Chronic Heart Failure (CHF)

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05262764
Collaborator
Eli Lilly and Company (Industry)
1,200
Enrollment
1
Location
27
Anticipated Duration (Months)
44.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Study objective is to investigate the safety and effectiveness of long-term daily use of JARDIANCE® Tablets in patients with chronic heart failure (CHF) under real-world use.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Anticipated Enrollment :
1200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Post Marketing Surveillance on Long Term Drug Use of JARDIANCE® Tablets in Patients With Chronic Heart Failure in Japan
Actual Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Patients with chronic heart failure (CHF)

Drug: JARDIANCE®
JARDIANCE®
Other Names:
  • empagliflozin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of Adverse Drug Reactions (ADRs) [Up to 52 weeks]

      Focus on hypoglycaemia, the events relevant volume depletion, influence of ketone body increased / ketoacidosis, renal impairment.

    Secondary Outcome Measures

    1. Incidence of all-cause death [Up to 52 weeks]

    2. Incidence of cardiovascular (CV) death [Up to 52 weeks]

    3. Incidence of hospitalizations for heart failure [Up to 52 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients with chronic heart failure (CHF) failure who are prescribed with JARDIANCE® Tablets in Japan

    • Patients who have never been treated with Empagliflozin (including treatment for type 2 diabetes mellitus (T2DM)) before enrolment

    Exclusion Criteria:
    • None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nippon Boehringer Ingelheim Co., Ltd. Tokyo Japan 1416017

    Sponsors and Collaborators

    • Boehringer Ingelheim
    • Eli Lilly and Company

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Boehringer Ingelheim
    ClinicalTrials.gov Identifier:
    NCT05262764
    Other Study ID Numbers:
    • 1245-0286
    First Posted:
    Mar 2, 2022
    Last Update Posted:
    Aug 11, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Heart Failure
    Empagliflozin

    Study Results

    No Results Posted as of Aug 11, 2022