BR1010 in Patients With Essential Hypertension Patients Who do Not Adequately Respond to Fimasartan/Amlodipine Combination

NCT ID: NCT03991442

Last Updated: 2021-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 257 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-17
• Study Completion Date: 2021-03-02

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

Conditions

Essential Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

BR1010 and Fimasartan/Amlodipine placebo

BR1010 or Fimasartan/Amlodipine

Group Type: EXPERIMENTAL

Fimasartan/Amlodipine

Intervention Type: DRUG

Active Comparator: a fixed dose combination of Fimasartan/Amlodipine or placebo

BR1010 placebo and Fimasartan/Amlodipine

BR1010 or Fimasartan/Amlodipine

Group Type: ACTIVE_COMPARATOR

Fimasartan/Amlodipine

Intervention Type: DRUG

Active Comparator: a fixed dose combination of Fimasartan/Amlodipine or placebo

Interventions

Fimasartan/Amlodipine

Active Comparator: a fixed dose combination of Fimasartan/Amlodipine or placebo

Intervention Type: DRUG

Other Intervention Names

BR1010 or placebo

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boryung Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Boryung Pharmaceutical Co., Ltd

Seoul, , South Korea

Countries

South Korea

Other Identifiers

BR-FAHC-CT-301

Identifier Type: -

Identifier Source: org_study_id