Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boryung Pharmaceutical Co., Ltd
Age
19–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | BR1010 in Patients With Essential Hypertension Patients Who do Not Adequately Respond to Fimasartan/Amlodipine Combination
