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

NCT ID: NCT05878561

Last Updated: 2024-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

248 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-09

Study Completion Date

2024-12-02

Brief Summary

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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

Detailed Description

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Conditions

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Essential Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Fimasartan + Indapamide

Treatment Period I, II

Group Type EXPERIMENTAL

Fimasartan + Indapamide

Intervention Type DRUG

a fixed dose combination

Fimasartan + Indapamide placebo

Treatment Period I, II

Group Type ACTIVE_COMPARATOR

Fimasartan + Indapamide placebo

Intervention Type DRUG

a fixed dose combination

Interventions

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Fimasartan + Indapamide

a fixed dose combination

Intervention Type DRUG

Fimasartan + Indapamide placebo

a fixed dose combination

Intervention Type DRUG

Other Intervention Names

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I : BR1015-3 + BR1015-2, II : BR1015-1 + BR1015-2 I : BR1015-3 + BR1015-4, II : BR1015-1 + BR1015-4

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boryung Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Bucheon-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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BR-FIC-CT-301

Identifier Type: -

Identifier Source: org_study_id