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

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

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

Study Overview

• Status: Completed
• Conditions: Essential Hypertension
• Intervention / Treatment: Drug: Fimasartan + Indapamide; Drug: Fimasartan + Indapamide placebo

• Study Type: Interventional
• Enrollment (Actual): 248
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Kyunggi-do
    • Bucheon-si, Kyunggi-do, Korea, Republic of, 14647
      • The Catholic University of Korea, Bucheon St.Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fimasartan + Indapamide; Treatment Period I, II	Drug: Fimasartan + Indapamide; a fixed dose combination; Other Names: I : BR1015-3 + BR1015-2, II : BR1015-1 + BR1015-2
Active Comparator: Fimasartan + Indapamide placebo; Treatment Period I, II	Drug: Fimasartan + Indapamide placebo; a fixed dose combination; Other Names: I : BR1015-3 + BR1015-4, II : BR1015-1 + BR1015-4

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	4weeks from Baseline Visit

Collaborators and Investigators

• Sponsor: Boryung Pharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2022
• Primary Completion (Actual): December 2, 2024
• Study Completion (Actual): December 2, 2024

Study Registration Dates

• First Submitted: May 18, 2023
• First Submitted That Met QC Criteria: May 18, 2023
• First Posted (Actual): May 26, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Essential Hypertension; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Diuretics; Natriuretic Agents; Antihypertensive Agents; Sodium Chloride Symporter Inhibitors; Indapamide
• Other Study ID Numbers: BR-FIC-CT-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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