Post Marketing Surveillance (PMS) of JARDIANCE in Chronic Heart Failure (CHF)
- Sponsor
- Boehringer Ingelheim
- Study ID
- NCT05262764
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- N/A - N/A
- Healthy Volunteers
- Not accepted
Interventions
- JARDIANCE® — DRUGTreatment was in accordance with the latest guidelines from The Japanese Circulation Society (JCS).
Study Details
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.
Key Dates
- Start date
- Apr 15, 2022
- Status verified
- Mar 2026
- Primary completion
- Jun 21, 2024
- Completion
- Jun 28, 2024
Study Design
- Enrollment
- 1,200 participants (actual)
Arms
- Arm: JARDIANCE®Patients in Japan with chronic heart failure who were prescribed JARDIANCE® tablets and who were never treated with Empagliflozin before enrolment. Treatment was in accordance with the latest guidelines from The Japanese Circulation Society (JCS). Patients were observed for up to 52 weeks after start of the treatment or until discontinuation of administration.
Primary Outcome Measure
Number of Subjects With Adverse Drug Reactions (ADRs) [ Time Frame: Up to 52 weeks ]
Related coverage on Hipa.ai
- Jardiance Post-Marketing Surveillance in CHF Reports Safety and Event RatesEmpagliflozin · Aug 6, 2025 · ClinicalTrials.gov
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