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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JARDIANCE® | Drug | Treatment was in accordance with the latest guidelines from The Japanese Circulation Society (JCS). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Adverse Drug Reactions (ADRs) | Number of subjects with ADRs (focus on hypoglycaemia, the events relevant for volume depletion, influence of ketone body increased / ketoacidosis, renal impairment). | Up to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of All-cause Death | Incidence of all-cause death. | Up to 52 weeks |
| Incidence of Cardiovascular Death | Incidence of cardiovascular death. |
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Inclusion Criteria:
Exclusion Criteria:
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Japanese patients with chronic heart failure (CHF).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nippon Boehringer Ingelheim Co., Ltd. | Tokyo | 1416017 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40512403 | Derived | Yamamoto K, Naito Y, Watanabe S. Safety and effectiveness of empagliflozin in Japanese patients with heart failure: a 1-year post-marketing surveillance study stratified by age. Expert Opin Drug Saf. 2025 Jun 18:1-9. doi: 10.1080/14740338.2025.2519835. Online ahead of print. |
| Label | URL |
|---|---|
| Related Info | View source |
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Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
For study documents -upon signing of a 'Document Sharing Agreement'.For study data -1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
This was a non-interventional, single arm study based on newly collected data Patients were observed for up to 52 weeks after start of the treatment with JARDIANCE® Tablets or until discontinuation of administration. Out of the 1200 registered subjects, 1166 had no protocol violations and were included in the safety set.
All subjects were screened for eligibility prior to participation in the trial. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
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| ID | Title | Description |
|---|---|---|
| FG000 | JARDIANCE® | Patients in Japan with chronic heart failure who were prescribed JARDIANCE® (Empagliflozin) tablets and who were never treated with Empagliflozin before enrolment (including treatment for type 2 diabetes mellitus). 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety set: all patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
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| ID | Title | Description |
|---|---|---|
| BG000 | JARDIANCE® | Patients in Japan with chronic heart failure who were prescribed JARDIANCE® (Empagliflozin) tablets and who were never treated with Empagliflozin before enrolment (including treatment for type 2 diabetes mellitus). 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With Adverse Drug Reactions (ADRs) | Number of subjects with ADRs (focus on hypoglycaemia, the events relevant for volume depletion, influence of ketone body increased / ketoacidosis, renal impairment). | Safety set: all patients who didn't have important Protocol Deviations regarding safety and regulatory issues. | Posted | Count of Participants | Participants | Up to 52 weeks |
|
Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | JARDIANCE® | Patients in Japan with chronic heart failure who were prescribed JARDIANCE® (Empagliflozin) tablets and who were never treated with Empagliflozin before enrolment (including treatment for type 2 diabetes mellitus). 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
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Since this surveillance was an observational, non-interventional study, it lacked the methodological rigour of a randomised controlled trial. The study was conducted in an unblinded manner and without controls.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | 001 | clintriage.rdg@boehringer-ingelheim.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 1, 2024 | Jun 2, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 14, 2024 | Jul 16, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
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| Up to 52 weeks |
| Incidence of Hospitalizations for Heart Failure | Incidence of hospitalizations for heart failure. | Up to 52 weeks |
| Lost to Follow-up |
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| Untraceable for changing hospital |
|
| Other than listed |
|
| Other |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| Secondary | Incidence of All-cause Death | Incidence of all-cause death. | Safety set: all patients who didn't have important Protocol Deviations regarding safety and regulatory issues. | Posted | Number | 95% Confidence Interval | Deaths per 100 person-years | Up to 52 weeks |
|
|
|
| Secondary | Incidence of Cardiovascular Death | Incidence of cardiovascular death. | Safety set: all patients who didn't have important Protocol Deviations regarding safety and regulatory issues. | Posted | Number | 95% Confidence Interval | Deaths per 100 person-years | Up to 52 weeks |
|
|
|
| Secondary | Incidence of Hospitalizations for Heart Failure | Incidence of hospitalizations for heart failure. | Safety set: all patients who didn't have important Protocol Deviations regarding safety and regulatory issues. | Posted | Number | 95% Confidence Interval | 1st Hospitalization per 100 person-years | Up to 52 weeks |
|
|
|
| 30 |
| 1,166 |
| 148 |
| 1,166 |
| 0 |
| 1,166 |
| Acute myocardial infarction | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Angina unstable | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Aortic valve incompetence | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Arrhythmia | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Cardiac failure acute | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Cardiac failure chronic | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Cardiac sarcoidosis | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Cardiac ventricular thrombosis | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Cardio-respiratory arrest | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Cardiomyopathy | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Sinus node dysfunction | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Ventricular extrasystoles | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Enterocolitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Inguinal hernia | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Large intestine perforation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Cardiac death | General disorders | MedDRA 27.0 | Systematic Assessment |
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| Death | General disorders | MedDRA 27.0 | Systematic Assessment |
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| Prosthetic cardiac valve thrombosis | General disorders | MedDRA 27.0 | Systematic Assessment |
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| Sudden cardiac death | General disorders | MedDRA 27.0 | Systematic Assessment |
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| Sudden death | General disorders | MedDRA 27.0 | Systematic Assessment |
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| Bile duct stone | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
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| Cholangitis | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
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| Abdominal wall abscess | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Abscess | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Arthritis bacterial | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Escherichia bacteraemia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Liver abscess | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Pneumonia aspiration | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Pneumonia bacterial | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Psoas abscess | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Pyelonephritis acute | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
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| Femur fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
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| Near drowning | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
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| Radius fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
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| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
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| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
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| Blood pressure decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
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| Blood urea increased | Investigations | MedDRA 27.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
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| Marasmus | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
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| Immobilisation syndrome | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| Angioimmunoblastic T-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
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| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
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| Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
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| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
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| Metastases to lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
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| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
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| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
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| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
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| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
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| Carotid artery occlusion | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Cerebellar haemorrhage | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Depressed level of consciousness | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Embolic cerebral infarction | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Hypoxic-ischaemic encephalopathy | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Lacunar infarction | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Loss of consciousness | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Taste disorder | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Thrombotic cerebral infarction | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Delirium | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
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| Transient psychosis | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
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| Azotaemia | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
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| Chronic kidney disease | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
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| Renal disorder | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
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| Pulmonary toxicity | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| Aortic aneurysm | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
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| Aortic dissection | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
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| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
|
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