Evaluating the effects of BR1018B and BR1018C on hypertension and cholesterol levels
A Multicenter, Randomized, Double-blind, Active-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Co-administrated BR1018B and BR1018C in Patients With Essential Hypertension and Primary Hypercholesterolemia
This study is testing if a new combination of medications can help people with high blood pressure and high cholesterol lower their levels enough to stop taking their current medications.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 156 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Boryung Pharmaceutical Co., Ltd Industry-sponsored |
| Locations | 2 sites (Daegu and 1 other locations) |
| Trial ID | NCT06165250 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the efficacy and safety of the combined administration of BR1018B and BR1018C in patients suffering from essential hypertension and primary hypercholesterolemia. Participants will be evaluated based on their ability to discontinue existing antihypertensive and antihyperlipidemic medications, while meeting specific blood pressure and lipid level criteria. The study will involve multiple interventions, including BR1018A, BR1018B, and BR1018C, to determine their effectiveness in managing these conditions.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with essential hypertension and primary hypercholesterolemia who can safely discontinue their current medications.
Not a fit: Patients who have uncontrolled hypertension or hyperlipidemia beyond the specified criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with essential hypertension and primary hypercholesterolemia.
How similar studies have performed: Other studies evaluating similar combinations of antihypertensive and antihyperlipidemic agents have shown promise, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
\<Inclusion Criteria\>
Screening Visit (V1)
* Patients with essential hypertension and primary hypercholesterolemia
* If patients are being treated with antihypertensive/antihyperlipidemic drugs at screening, they should be determined to be medically reasonable by investigator about discontinuing existing antihypertensive/antihyperlipidemic drugs during the clinical trial
* Patients under the following criteria at screening:
* Patients who meet a fasting triglyceride (TG) \< 400 mg/dL and LDL-C ≤ 250 mg/dL
* Patients who meet the following criteria, depending on whether antihypertensive drugs were administered within the last 4 weeks
1. Naïve : 140 mmHg ≤ MSSBP \< 180 mmHg and MSDBP \< 110 mmHg
2. Use antihypertensive drugs : 130 mmHg ≤ MSSBP \< 180 mmHg and MSDBP \< 110 mmHg
Baseline Visit (V2)
* Patients who meet the following criteria of blood pressure measured in selected reference arm at baseline (According to the clinical situation of each subject, Follow the blood pressure standards(Refer to 2022 The Korean Society of Hypertension Guideline))
* 140 mmHg(or 130 mmHg) ≤ MSSBP \< 180 mmHg
* MSDBP \< 110 mmHg
* Patients who meet fasting serum lipid profile test levels (LDL-C and TG) correspond to cardiovascular risk and risk factors at baseline (Refer to 2022 Korean Guidelines for the Management of Dyslipidemia (the 5th edition))
\<Exclusion Criteria\>
* 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 blood pressure results showing MSSBP ≥ 180 mmHg or MSDBP ≥ 110 mmHg at screening(V1, both arms) and baseline(V2, selected reference arm)
* Patients with a history of secondary hypertension or suspected secondary hypertension; (e.g., coarctation of the aorta, hyperaldosteronism, renal artery stenosis, renal hypertension, pheochromocytoma, Cushing's syndrome and polycystic kidney disease, etc.)
* Patients with a history of secondary hyperlipidemia or suspected hyperlipidemia; (e.g., Chronic renal failure, nephrotic syndrome, dysproteinemia, obstructive liver disease, Cushing's syndrome, hypothyroidism, etc.)
* Patients with hyportensive shock
* Patients with orthostatic hypotension accompanied by symptoms
Where this trial is running
Daegu and 1 other locations
- Keimyung University Dongsan Hospital — Daegu, Korea, Republic of (Recruiting)
- Seoul National University Boramae Medical Center — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Shin-young Oh
- Email: syoh@boryung.co.kr
- Phone: +82-2-708-8000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.