Essential Hypertension
Conditions
Keywords
Hypertension, Fimasartan
Brief summary
Evaluated the incidence and characteristics of adverse events during the treatment for Kanarb tablet.
Detailed description
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)
Interventions
None listed
Sponsors
Boryung Pharmaceutical Co., Ltd
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with essential hypertension 2. Taking Kanarb tablet® (fimasartan) as prescribed previously (within 1 month) or newly 3. Male and female adults aged 20 years or older 4. Voluntarily provided a written consent to participate in the study
Exclusion criteria
1. Patients with hypersensitivity to this drug or the ingredients of this drug 2. Pregnant or breast-feeding women 3. Patients on renal dialysis 4. Patients with moderate to severe hepatic impairment 5. Patients with biliary atresia 6. Genetic disorders such as galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption 7. Patients considered inappropriate for taking Kanarb tablet® (fimasartan) by investigator 8. Clinically significant abnormal liver function (AST, ALT ≥2 x upper limit of normal (ULN); TB ≥1.5 ULN)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing AEs or ADRs | up to 12 months | Number of participants experiencing AEs (or ADRs) during the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Persistence Rate of Fimasartan | up to 12 months | Treatment persistence rate of Kanarb tablet® (fimasartan) until the end of 1-year study |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Safety Set Patients with essential hypertension who received Kanarb tablet® (fimasartan) | 601 |
| Total | 601 |
Baseline characteristics
| Characteristic | Safety Set | — |
|---|---|---|
| Age, Continuous | 59.65 years STANDARD_DEVIATION 11.97 | — |
| BMI | 25.34 kg/m2 STANDARD_DEVIATION 3.31 | — |
| Duration of Hypertension | 6.47 years STANDARD_DEVIATION 8.52 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 267 Participants | — |
| Sex: Female, Male Male | 334 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 601 |
| other Total, other adverse events | 59 / 601 |
| serious Total, serious adverse events | 33 / 601 |
Outcome results
Primary
Number of Participants Experiencing AEs or ADRs
Number of participants experiencing AEs (or ADRs) during the study
Time frame: up to 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Safety Set | Number of Participants Experiencing AEs or ADRs | AE | 184 Participants |
| Safety Set | Number of Participants Experiencing AEs or ADRs | ADR | 59 Participants |
Secondary
Treatment Persistence Rate of Fimasartan
Treatment persistence rate of Kanarb tablet® (fimasartan) until the end of 1-year study
Time frame: up to 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Safety Set | Treatment Persistence Rate of Fimasartan | Study completion | 371 Participants |
| Safety Set | Treatment Persistence Rate of Fimasartan | Study withdrawn | 230 Participants |