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

Essential Hypertension Clinical Trial

— FINAL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03991442
• Other study ID #: BR-FAHC-CT-301
• Status: Completed
• Phase: Phase 3
• Start date: June 17, 2019
• Est. completion date: March 2, 2021

Study information

• Verified date: July 2021
• Source: Boryung Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 257
• Est. completion date: March 2, 2021
• Est. primary completion date: March 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Boryung Pharmaceutical Co., Ltd	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Boryung Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sitting systolic blood pressure	The change of sitting systolic blood pressure	8weeks from Baseline Visit
Secondary	sitting systolic blood pressure	The change of sitting systolic blood pressure	2weeks and 4weeks from Baseline Visit
Secondary	sitting systolic blood pressure and sitting diastolic blood pressure	The change of sitting systolic blood pressure and sitting diastolic blood pressure	2weeks, 4weeks and 8weeks from Baseline Visit
Secondary	The ratio of subjects who get normalized blood pressure	The ratio of subjects who get normalized blood pressure	2weeks, 4weeks and 8weeks from Baseline Visit
Secondary	Response Rate	Response Rate	2weeks, 4weeks and 8weeks from Baseline Visit