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

NCT03991442 | Completed Phase 3

• 1 other identifier: BR-FAHC-CT-301
• Study Type: interventional
• Target: 257
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• sitting systolic blood pressure

  The change of sitting systolic blood pressure

  8weeks from Baseline Visit

Secondary Outcomes (4)

• sitting systolic blood pressure

  2weeks and 4weeks from Baseline Visit

• sitting systolic blood pressure and sitting diastolic blood pressure

  2weeks, 4weeks and 8weeks from Baseline Visit

• The ratio of subjects who get normalized blood pressure

  2weeks, 4weeks and 8weeks from Baseline Visit

• Response Rate

  2weeks, 4weeks and 8weeks from Baseline Visit

Study Arms (2)

BR1010 and Fimasartan/Amlodipine placebo

EXPERIMENTAL

BR1010 or Fimasartan/Amlodipine

Drug: Fimasartan/Amlodipine

BR1010 placebo and Fimasartan/Amlodipine

ACTIVE COMPARATOR

BR1010 or Fimasartan/Amlodipine

Drug: Fimasartan/Amlodipine

Interventions

Fimasartan/Amlodipine DRUG

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

Also known as: BR1010 or placebo

BR1010 and Fimasartan/Amlodipine placebo; BR1010 placebo and Fimasartan/Amlodipine

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 qualify if:

• Difference of SiSBP ≥ 20 mmHg and SiDBP ≥ 10 mmHg in 3 blood pressure measurements in the selected reference arm at the screening visit
• Blood pressure results showing sitDBP ≥ 120 mmHg at screening and baseline visit(Visit 1; Both Arm, Visit 2: Selected Arm)
• Treatment Compliance of Fimasartan/Amlodipine 30/5mg \< 70%
• Heart failure(New York Heart Association class 3 and 4), ischemic heart disease, peripheral vascular disease
• Percutaneous Coronary Artery within 6 months prior to study
• Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter; or other arrhythmia conditions that are determined to be clinically significant by the investigator
• Patients who have history of severe cerebrovascular disease within 6 months prior to study
• Type I Diabetes Mellitus or Uncontrolled Type II Diabetes Mellitus(HbA1c \> 9% at screening visit
• Patients who have history of severe or malignant retinopathy within 6 months prior to study
• Pregnant or lactating women
• Planning pregnancy during the study period or have childbearing potential but are not using acceptable contraceptive methods
• Patients taking other clinical trial drugs within 4 weeks from the time of visit for screening
• Patients who are judged unsuitable to participate in this study by investigator

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead

Study Sites (1)

Boryung Pharmaceutical Co., Ltd

Seoul, South Korea

Location

MeSH Terms

Conditions

Essential Hypertension

Interventions

fimasartan; Amlodipine

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: June 19, 2019
• Study Start: June 17, 2019
• Primary Completion: March 2, 2021
• Study Completion: March 2, 2021
• Last Updated: July 30, 2021

Record last verified: 2021-07

Locations

KR (1)