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

Overview

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

Full Title of Study: “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

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Double (Participant, Investigator)
• Study Primary Completion Date: October 2024

Interventions

• Drug: Fimasartan + Indapamide
  • a fixed dose combination
• Drug: Fimasartan + Indapamide placebo
  • a fixed dose combination

Arms, Groups and Cohorts

• Experimental: Fimasartan + Indapamide
  • Treatment Period I, II
• Active Comparator: Fimasartan + Indapamide placebo
  • Treatment Period I, II

Clinical Trial Outcome Measures

Primary Measures

• Sitting systolic blood pressure
  • Time Frame: 8weeks from Baseline Visit
  • The change of sitting systolic blood pressure

Secondary Measures

• Sitting systolic blood pressure
  • Time Frame: 4weeks from Baseline Visit
  • The change of sitting systolic blood pressure

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Boryung Pharmaceutical Co., Ltd
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Contact(s)
  • Shinyoung Oh, +82-2-708-8000, syoh@boryung.co.kr