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

NCT05878561 | Completed Phase 3

• 1 other identifier: BR-FIC-CT-301
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

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

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 (1)

• Sitting systolic blood pressure

  4weeks from Baseline Visit

Study Arms (2)

Fimasartan + Indapamide

EXPERIMENTAL

Treatment Period I, II

Drug: Fimasartan + Indapamide

Fimasartan + Indapamide placebo

ACTIVE COMPARATOR

Treatment Period I, II

Drug: Fimasartan + Indapamide placebo

Interventions

Fimasartan + Indapamide DRUG

a fixed dose combination

Also known as: I : BR1015-3 + BR1015-2, II : BR1015-1 + BR1015-2

Fimasartan + Indapamide

Fimasartan + Indapamide placebo DRUG

a fixed dose combination

Also known as: I : BR1015-3 + BR1015-4, II : BR1015-1 + BR1015-4

Fimasartan + Indapamide placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead

Study Sites (1)

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

Bucheon-si, Gyeonggi-do, 14647, South Korea

Location

MeSH Terms

Conditions

Essential Hypertension

Interventions

fimasartan; Indapamide

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

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

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: May 26, 2023
• Study Start: November 9, 2022
• Primary Completion: December 2, 2024
• Study Completion: December 2, 2024
• Last Updated: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)