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Evaluated the incidence and characteristics of adverse events during the treatment for Kanarb tablet.
This study is designed to evaluate the incidence and characteristics (profile, relationship to the study drug, severity, and outcome) of adverse events (AEs) observed during 1-year treatment with Kanarb tablet® (fimasartan)
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing AEs or ADRs | Number of participants experiencing AEs (or ADRs) during the study | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Persistence Rate of Fimasartan | Treatment persistence rate of Kanarb tablet® (fimasartan) until the end of 1-year study | up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Hypertension Patients
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| Name | Affiliation | Role |
|---|---|---|
| Myung Sook Hong | Boryung Pharmaceutical Co., Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yoon Jun Kim | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32308367 | Derived | Oh GC, Joo KW, Kim MA, Choi DJ, Kim YJ, Lee HY. Long-Term Safety of a Novel Angiotensin Receptor Blocker, Fimasartan, According to the Absence or Presence of Underlying Liver Disease in Korean Hypertensive Patients: A Prospective, 12-Month, Observational Study. Drug Des Devel Ther. 2020 Apr 3;14:1341-1349. doi: 10.2147/DDDT.S233174. eCollection 2020. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Safety Set | Patients with essential hypertension who received Kanarb tablet® (fimasartan) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Safety Set | Patients with essential hypertension who received Kanarb tablet® (fimasartan) |
| 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 Participants Experiencing AEs or ADRs | Number of participants experiencing AEs (or ADRs) during the study | Posted | Count of Participants | Participants | up to 12 months |
|
|
1 year
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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 | Safety Set | Patients with essential hypertension who received Kanarb tablet® (fimasartan) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Myung Sook Hong | Boryung Pharmaceutical Co., Ltd | 82-2-708-8238 | mshong@boryung.co.kr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 22, 2016 | Aug 29, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| 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 |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
| Duration of Hypertension | Mean | Standard Deviation | years |
|
|
| Secondary | Treatment Persistence Rate of Fimasartan | Treatment persistence rate of Kanarb tablet® (fimasartan) until the end of 1-year study | Posted | Count of Participants | Participants | up to 12 months |
|
|
|
| 0 |
| 601 |
| 33 |
| 601 |
| 59 |
| 601 |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
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| Laryngeal papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
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| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Femur fracture | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
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| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Peripheral artery restenosis | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Ulna fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
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| Azotaemia | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
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| Glomerulonephritis membranous | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Monarthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
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| Coronary artery stenosis | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Infective spondylitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Haemorrhage intracranial | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Aortic dissection | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
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| Varicose vein | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
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| Cataract | Eye disorders | MedDRA 19.0 | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Drug hypersensitivity | Immune system disorders | MedDRA 19.0 | Systematic Assessment |
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| Delirium | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Dizziness postural | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA 19.0 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
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| Blood pressure decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
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| Liver function test abnormal | Investigations | MedDRA 19.0 | Systematic Assessment |
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| Liver function test increased | Investigations | MedDRA 19.0 | Systematic Assessment |
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| Dyspepsi | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Epigastric discomfort | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Chills | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Blood pressure inadequately controlled | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
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| Flushing | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
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| Orthostatic hypotension | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
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| Hepatitis | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
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| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
|
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