NCT05878561CompletedPhase 3
A Study to Evaluate the Efficacy and Safety of BR1015 Combination Therapy
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
Source: ClinicalTrials.gov · Last updated 20 Dec 2024
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 248 (actual)
- First submitted
- 18 May 2023
- Start date
- 9 Nov 2022
- Primary completion date
- 2 Dec 2024
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Diseases
- High blood pressure
- NCT number
- NCT05878561
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 248
- From 9 Nov 2022 to the primary completion date, 2 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Catholic University of Korea, Bucheon St. Mary's Hospital Coordinator of this site? Confirm its status | Bucheon-si | South Korea | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.