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

Essential Hypertension Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05878561
• Other study ID #: BR-FIC-CT-301
• Status: Recruiting
• Phase: Phase 3
• Start date: November 9, 2022
• Est. completion date: October 2024

Study information

• Verified date: May 2024
• Source: Boryung Pharmaceutical Co., Ltd
• Contact: Shinyoung Oh
• Phone: +82-2-708-8000
• Email: syoh[@]boryung.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 244
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

• 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

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• Fimasartan + Indapamide
a fixed dose combination
• Fimasartan + Indapamide placebo
a fixed dose combination

Locations

Country	Name	City	State
Korea, Republic of	The Catholic University of Korea, Bucheon St.Mary's Hospital	Bucheon-si	Kyunggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Boryung Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sitting systolic blood pressure	The change of sitting systolic blood pressure	8weeks from Baseline Visit
Secondary	Sitting systolic blood pressure	The change of sitting systolic blood pressure	4weeks from Baseline Visit