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Completed

NCT Number: NCT05878561

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

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

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Fimasartan + Indapamide

Drug

a fixed dose combination

Other names: I : BR1015-3 + BR1015-2, II : BR1015-1 + BR1015-2

Fimasartan + Indapamide placebo

Drug

a fixed dose combination

Other names: I : BR1015-3 + BR1015-4, II : BR1015-1 + BR1015-4

Primary outcomes

  1. Sitting systolic blood pressure

    Time frame: 8weeks from Baseline Visit

    The change of sitting systolic blood pressure

Secondary outcomes

  1. Sitting systolic blood pressure

    Time frame: 4weeks from Baseline Visit

    The change of sitting systolic blood pressure

Sponsors and collaborators

Lead sponsor

Boryung Pharmaceutical Co., Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 26, 2023
Registry last updated
Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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