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A Study to Evaluate the Efficacy and Safety of BR1015 Combination Therapy

Primary Purpose

Essential Hypertension

Status
Recruiting
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Fimasartan + Indapamide
Fimasartan + Indapamide placebo
Sponsored by
Boryung Pharmaceutical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with uncontrolled essential hypertension at screening(V1) under the following criteria: Naïve : 140 mmHg ≤ SiSBP < 180 mmHg Use antihypertensive drugs : 130 mmHg ≤ SiSBP < 180 mmHg Patients with uncontrolled essential hypertension at randomization(V2) after Fimasartan 30mg monotherapy for 4 weeks under the following criteria: Selected reference arm : 140 mmHg ≤ SiSBP < 180 mmHg (For patients with cardiovascular disease, diabetes or chronic kidney disease (CKD) with albuminuria, 130 mmHg ≤ SiSBP < 180 mmHg) Treatment compliance of Fimasartan 30 mg ≥70% at baseline visit (V2) Voluntarily provided a written consent to participate in this clinical study Able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion Exclusion Criteria: Patients taking three or more antihypertensive drugs of different families Patients with blood pressure results showing SiSBP ≥ 180 mmHg or SiDBP ≥ 110 mmHg in the selected reference arm at screening(V1) and randomization(V2) Patients with a difference of SiSBP ≥ 20 mmHg and SiDBP ≥ 10 mmHg in blood pressure measured three times on both arms at screening(V1) Patients with secondary hypertension: Secondary hypertension is not limited to the following diseases; (e.g., coarctation of the aorta, Primary hyperaldosteronism, renal artery stenosis, Cushing's syndrome, pheochromocytoma and polycystic kidney disease, etc.) Patients with orthostatic hypotension accompanied by symptoms Patients who need to be administered in combination with antihypertensive drugs other than investigational product while participating in clinical trials

Sites / Locations

  • The Catholic University of Korea, Bucheon St.Mary's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fimasartan + Indapamide

Fimasartan + Indapamide placebo

Arm Description

Treatment Period I, II

Treatment Period I, II

Outcomes

Primary Outcome Measures

Sitting systolic blood pressure
The change of sitting systolic blood pressure

Secondary Outcome Measures

Sitting systolic blood pressure
The change of sitting systolic blood pressure

Full Information

First Posted
May 18, 2023
Last Updated
May 18, 2023
Sponsor
Boryung Pharmaceutical Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05878561
Brief Title
A Study to Evaluate the Efficacy and Safety of BR1015 Combination Therapy
Official Title
A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of BR1015 Combination Therapy in Comparison With Fimasartan Monotherapy for Essential Hypertension Patients Not Adequately Responded by Fimasartan 30 mg
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 9, 2022 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boryung Pharmaceutical Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this clinical trial is to evaluate the efficacy and safety of BR1015 Combination therapy group in comparison with Fimasartan monotherapy group at Week 8 for essential hypertension patients who do not adequately responded by Fimasartan 30 mg

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
244 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fimasartan + Indapamide
Arm Type
Experimental
Arm Description
Treatment Period I, II
Arm Title
Fimasartan + Indapamide placebo
Arm Type
Active Comparator
Arm Description
Treatment Period I, II
Intervention Type
Drug
Intervention Name(s)
Fimasartan + Indapamide
Other Intervention Name(s)
I : BR1015-3 + BR1015-2, II : BR1015-1 + BR1015-2
Intervention Description
a fixed dose combination
Intervention Type
Drug
Intervention Name(s)
Fimasartan + Indapamide placebo
Other Intervention Name(s)
I : BR1015-3 + BR1015-4, II : BR1015-1 + BR1015-4
Intervention Description
a fixed dose combination
Primary Outcome Measure Information:
Title
Sitting systolic blood pressure
Description
The change of sitting systolic blood pressure
Time Frame
8weeks from Baseline Visit
Secondary Outcome Measure Information:
Title
Sitting systolic blood pressure
Description
The change of sitting systolic blood pressure
Time Frame
4weeks from Baseline Visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with uncontrolled essential hypertension at screening(V1) under the following criteria: Naïve : 140 mmHg ≤ SiSBP < 180 mmHg Use antihypertensive drugs : 130 mmHg ≤ SiSBP < 180 mmHg Patients with uncontrolled essential hypertension at randomization(V2) after Fimasartan 30mg monotherapy for 4 weeks under the following criteria: Selected reference arm : 140 mmHg ≤ SiSBP < 180 mmHg (For patients with cardiovascular disease, diabetes or chronic kidney disease (CKD) with albuminuria, 130 mmHg ≤ SiSBP < 180 mmHg) Treatment compliance of Fimasartan 30 mg ≥70% at baseline visit (V2) Voluntarily provided a written consent to participate in this clinical study Able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion Exclusion Criteria: Patients taking three or more antihypertensive drugs of different families Patients with blood pressure results showing SiSBP ≥ 180 mmHg or SiDBP ≥ 110 mmHg in the selected reference arm at screening(V1) and randomization(V2) Patients with a difference of SiSBP ≥ 20 mmHg and SiDBP ≥ 10 mmHg in blood pressure measured three times on both arms at screening(V1) Patients with secondary hypertension: Secondary hypertension is not limited to the following diseases; (e.g., coarctation of the aorta, Primary hyperaldosteronism, renal artery stenosis, Cushing's syndrome, pheochromocytoma and polycystic kidney disease, etc.) Patients with orthostatic hypotension accompanied by symptoms Patients who need to be administered in combination with antihypertensive drugs other than investigational product while participating in clinical trials
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shinyoung Oh
Phone
+82-2-708-8000
Email
syoh@boryung.co.kr
Facility Information:
Facility Name
The Catholic University of Korea, Bucheon St.Mary's Hospital
City
Bucheon-si
State/Province
Kyunggi-do
ZIP/Postal Code
14647
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang-Hyun Ihm, Ph.D
Phone
+82-32-340-7027
Email
limsh@catholic.ac.kr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study to Evaluate the Efficacy and Safety of BR1015 Combination Therapy

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