A Study to Evaluate the Efficacy and Safety of Co-administrated BR1018B and BR1018C

Phase 3

Recruiting

• Conditions: Essential Hypertension; Primary Hypercholesterolemia
• Interventions: Drug: BR1018A-1; Drug: BR1018A; Drug: BR1018B; Drug: BR1018B-1; Drug: BR1018C; Drug: BR1018C-1

• Registration Number: NCT06165250
• Lead Sponsor: Boryung Pharmaceutical Co., Ltd

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-03
• Study First Submitted QC: 2023-12-03
• Study First Posted: 2023-12-11
• Status Verified: 2024-04
• Study Start: 2024-04-17
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-23
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BR1018A-1 + BR1018B + BR1018C	BR1018B	-
BR1018A-1 + BR1018B + BR1018C	BR1018A-1	-
BR1018A-1 + BR1018B + BR1018C	BR1018C	-
BR1018A + BR1018B-1 + BR1018C	BR1018A	-
BR1018A + BR1018B-1 + BR1018C	BR1018B-1	-
BR1018A + BR1018B-1 + BR1018C	BR1018C	-
BR1018A-1 + BR1018B + BR1018C-1	BR1018A-1	-
BR1018A-1 + BR1018B + BR1018C-1	BR1018B	-
BR1018A-1 + BR1018B + BR1018C-1	BR1018C-1	-

Primary Outcome Measures

Name	Time	Method
LDL-C	8weeks from Baseline Visit	The percent of change in LDL-C from baseline in BR1018A-1+BR1018B+BR1018C at Week 8 compared to BR1018A-1+BR1018B+BR1018C-1
Mean sitting systolic blood pressure	8weeks from Baseline Visit	The change of mean sitting systolic blood pressure from baseline in BR1018A-1+BR1018B+BR1018C at Week 8 compared to BR1018A+BR1018B-1+BR1018C

Trial Locations

Locations (2)

Keimyung University Dongsan Hospital; 🇰🇷 Daegu, Korea, Republic of

Seoul National University Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of