Clincosm LogoSign in Get a demo

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

Sponsor
Boryung Pharmaceutical Co., Ltd (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05878561
Collaborator
(none)
244
Enrollment
1
Location
2
Arms
22.7
Anticipated Duration (Months)
10.7
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Fimasartan + Indapamide
  • Drug: Fimasartan + Indapamide placebo
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
244 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
Nov 9, 2022
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Sitting systolic blood pressure [8weeks from Baseline Visit]

      The change of sitting systolic blood pressure

    Secondary Outcome Measures

    1. Sitting systolic blood pressure [4weeks from Baseline Visit]

      The change of sitting systolic blood pressure

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Catholic University of Korea, Bucheon St.Mary's Hospital Bucheon-si Kyunggi-do Korea, Republic of 14647

    Sponsors and Collaborators

    • Boryung Pharmaceutical Co., Ltd

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Boryung Pharmaceutical Co., Ltd
    ClinicalTrials.gov Identifier:
    NCT05878561
    Other Study ID Numbers:
    • BR-FIC-CT-301
    First Posted:
    May 26, 2023
    Last Update Posted:
    May 26, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hypertension
    Essential Hypertension
    Indapamide

    Study Results

    No Results Posted as of May 26, 2023