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

Phase 3

Completed

• Conditions: Essential Hypertension
• Interventions: Drug: Fimasartan + Indapamide; Drug: Fimasartan + Indapamide placebo

• Registration Number: NCT05878561
• Lead Sponsor: Boryung Pharmaceutical Co., Ltd

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-09
• Study First Submitted: 2023-05-18
• Study First Submitted QC: 2023-05-18
• Study First Posted: 2023-05-26
• Status Verified: 2024-12
• Primary Completion: 2024-12-02
• Study Completion: 2024-12-02
• Last Update Submitted: 2024-12-18
• Last Update Posted: 2024-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 248

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fimasartan + Indapamide	Fimasartan + Indapamide	Treatment Period I, II
Fimasartan + Indapamide placebo	Fimasartan + Indapamide placebo	Treatment Period I, II

Primary Outcome Measures

Name	Time	Method
Sitting systolic blood pressure	8weeks from Baseline Visit	The change of sitting systolic blood pressure

Secondary Outcome Measures

Name	Time	Method
Sitting systolic blood pressure	4weeks from Baseline Visit	The change of sitting systolic blood pressure

Trial Locations

Locations (1)

The Catholic University of Korea, Bucheon St.Mary's Hospital; 🇰🇷 Bucheon-si, Kyunggi-do, Korea, Republic of