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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05878561
Other study ID # BR-FIC-CT-301
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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