Clinical trial NCT06165250: A Study to Evaluate the Efficacy and Safety of Co-administrated BR1018B and BR1018C
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Essential Hypertension
Primary Hypercholesterolemia
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-12-11
Enrollment: 156
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical trial is to evaluate the efficacy and safety of co-administrated BR1018B and BR1018C in patients with essential hypertension and primary hypercholesterolemia


Eligibility 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

Primary outcomes:
measure: Mean sitting systolic blood pressure
timeFrame: 8weeks from Baseline Visit
measure: LDL-C
timeFrame: 8weeks from Baseline Visit
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Boramae Medical Center
Study officials:
References: