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

• Status: Recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boryung Pharmaceutical Co., Ltd
• Treatments: Indapamide

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