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NCT05262764 Clinical Trial

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

Heart Failure Clinical Trial

Official title:
Post Marketing Surveillance on Long Term Drug Use of JARDIANCE® Tablets in Patients With Chronic Heart Failure in Japan

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05262764
Other study ID # 1245-0286
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date April 1, 2022
Est. completion date June 30, 2024

Study information
Verified date April 2024
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 1201
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• JARDIANCE®
JARDIANCE®

Locations
Country Name City State
Japan Nippon Boehringer Ingelheim Co., Ltd. Tokyo

Sponsors (2)
Lead Sponsor Collaborator
Boehringer Ingelheim Eli Lilly and Company

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of Adverse Drug Reactions (ADRs) Focus on hypoglycaemia, the events relevant volume depletion, influence of ketone body increased / ketoacidosis, renal impairment. Up to 52 weeks
Secondary Incidence of all-cause death Up to 52 weeks
Secondary Incidence of cardiovascular (CV) death Up to 52 weeks
Secondary Incidence of hospitalizations for heart failure Up to 52 weeks
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