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

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

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

Study Overview

• Status: Completed
• Conditions: Essential Hypertension
• Intervention / Treatment: Drug: Fimasartan/Amlodipine

• Study Type: Interventional
• Enrollment (Actual): 257
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Boryung Pharmaceutical Co., Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BR1010 and Fimasartan/Amlodipine placebo; BR1010 or Fimasartan/Amlodipine	Drug: Fimasartan/Amlodipine; Active Comparator: a fixed dose combination of Fimasartan/Amlodipine or placebo; Other Names: BR1010 or placebo
Active Comparator: BR1010 placebo and Fimasartan/Amlodipine; BR1010 or Fimasartan/Amlodipine	Drug: Fimasartan/Amlodipine; Active Comparator: a fixed dose combination of Fimasartan/Amlodipine or placebo; Other Names: BR1010 or placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sitting systolic blood pressure	The change of sitting systolic blood pressure	8weeks from Baseline Visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sitting systolic blood pressure	The change of sitting systolic blood pressure	2weeks and 4weeks from Baseline Visit
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
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
Response Rate	Response Rate	2weeks, 4weeks and 8weeks from Baseline Visit

Collaborators and Investigators

• Sponsor: Boryung Pharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2019
• Primary Completion (Actual): March 2, 2021
• Study Completion (Actual): March 2, 2021

Study Registration Dates

• First Submitted: June 17, 2019
• First Submitted That Met QC Criteria: June 17, 2019
• First Posted (Actual): June 19, 2019

Study Record Updates

• Last Update Posted (Actual): July 30, 2021
• Last Update Submitted That Met QC Criteria: July 28, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Amlodipine
• Other Study ID Numbers: BR-FAHC-CT-301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No