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

Boryung

Status and phase: Completed; Phase 3

Conditions: Essential Hypertension

Treatments: Drug: Fimasartan + Indapamide; Drug: Fimasartan + Indapamide placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05878561

BR-FIC-CT-301

Details and patient eligibility

About

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

Enrollment: 248 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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248 participants in 2 patient groups

Fimasartan + Indapamide

Experimental group

Description:

Treatment Period I, II

Treatment:

Drug: Fimasartan + Indapamide

Fimasartan + Indapamide placebo

Active Comparator group

Description:

Treatment Period I, II

Treatment:

Drug: Fimasartan + Indapamide placebo