Clinical trial NCT03991442: BR1010 in Patients With Essential Hypertension Patients Who do Not Adequately Respond to Fimasartan/Amlodipine Combination
Official title: A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of BR1010 in Essential Hypertension Patients Who do Not Adequately Respond to Fimasartan/Amlodipine Combination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Essential Hypertension
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2019-06-19
Enrollment: 257
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: sitting systolic blood pressure
timeFrame: 8weeks from Baseline Visit
Secondary outcomes:
measure: sitting systolic blood pressure
timeFrame: 2weeks and 4weeks from Baseline Visit
measure: sitting systolic blood pressure and sitting diastolic blood pressure
timeFrame: 2weeks, 4weeks and 8weeks from Baseline Visit
measure: The ratio of subjects who get normalized blood pressure
timeFrame: 2weeks, 4weeks and 8weeks from Baseline Visit
measure: Response Rate
timeFrame: 2weeks, 4weeks and 8weeks from Baseline Visit
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Boryung Pharmaceutical Co., Ltd
Study officials:
References: