Essential Hypertension
Conditions
Brief summary
The objective of this clinical study is to evaluate the efficacy and safety by comparing the BR1010 treatment group to the fimasartan/amlodipine treatment group at Week 8 in patients with essential hypertension who do not adequately respond to Fimasartan/Amlodipine combination
Interventions
Active Comparator: a fixed dose combination of Fimasartan/Amlodipine or placebo
Sponsors
Boryung Pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1.Voluntarily provided a written consent to participate in this clinical study 2.19 years old or above Koreans living in Korea 3.Patients with uncontrolled essential hypertension at screening time(Visit 1) * Use antihypertensive drugs:140 mmHg ≤ sitSBP \< 200 mmHg * Naïve: 160 mmHg ≤ sitSBP \< 200 mmHg 4.Patients with uncontrolled hypertension after Fimasartan/Amlodipine 30/5mg treatment for 4 weeks at randomization(Visit 2) (Selected Arm:140 mmHg ≤ sitSBP \< 200 mmHg 5.Able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion
Exclusion criteria
1. Difference of SiSBP ≥ 20 mmHg and SiDBP ≥ 10 mmHg in 3 blood pressure measurements in the selected reference arm at the screening visit 2. Blood pressure results showing sitDBP ≥ 120 mmHg at screening and baseline visit(Visit 1; Both Arm, Visit 2: Selected Arm) 3. Treatment Compliance of Fimasartan/Amlodipine 30/5mg \< 70% 4. Heart failure(New York Heart Association class 3 and 4), ischemic heart disease, peripheral vascular disease 5. Percutaneous Coronary Artery within 6 months prior to study 6. Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter; or other arrhythmia conditions that are determined to be clinically significant by the investigator 7. Patients who have history of severe cerebrovascular disease within 6 months prior to study 8. Type I Diabetes Mellitus or Uncontrolled Type II Diabetes Mellitus(HbA1c \> 9% at screening visit 9. Patients who have history of severe or malignant retinopathy within 6 months prior to study 10. Pregnant or lactating women 11. Planning pregnancy during the study period or have childbearing potential but are not using acceptable contraceptive methods 12. Patients taking other clinical trial drugs within 4 weeks from the time of visit for screening 13. Patients who are judged unsuitable to participate in this study by investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| sitting systolic blood pressure | 8weeks from Baseline Visit | The change of sitting systolic blood pressure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| sitting systolic blood pressure | 2weeks and 4weeks from Baseline Visit | The change of sitting systolic blood pressure |
| sitting systolic blood pressure and sitting diastolic blood pressure | 2weeks, 4weeks and 8weeks from Baseline Visit | The change of sitting systolic blood pressure and sitting diastolic blood pressure |
| The ratio of subjects who get normalized blood pressure | 2weeks, 4weeks and 8weeks from Baseline Visit | The ratio of subjects who get normalized blood pressure |
| Response Rate | 2weeks, 4weeks and 8weeks from Baseline Visit | Response Rate |
Countries
South Korea
Outcome results
None listed