NCT05930028

A Study to Evaluate the Efficacy and Safety of BR1017A and BR1017B Combination Therapy in Essential Hypertension Patients With Primary Hypercholesterolemia

A Randomized, Double-blind, Multi-center, Phase III Trial to Evaluate the Efficacy and Safety of BR1017A and BR1017B Combination Therapy in Essential Hypertension Patients With Primary Hypercholesterolemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 148 (actual)
• Sponsor: Boryung Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The objective of this clinical study is to evaluate the efficacy and safety by comparing BR1017A+BR1017B treatment group to BR1017A treatment group and BR1017B treatment group respectively at Week 8 in essential hypertension patients with primary hypercholesterolemia

Conditions

• Essential Hypertension
• Primary Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	Fimasartan	Subjects take the investigational products once a day for 8 weeks.
DRUG	Ezetimibe/Atorvastatin	Subjects take the investigational products once a day for 8 weeks.
DRUG	Fimasartan Placebo	Subjects take the investigational products once a day for 8 weeks.
DRUG	Ezetimibe/Atorvastatin Placebo	Subjects take the investigational products once a day for 8 weeks.

Timeline

• Start date: 2023-07-13
• Primary completion: 2024-09-05
• Completion: 2024-09-05
• First posted: 2023-07-05
• Last updated: 2024-10-18

Locations

1 site across 1 country: South Korea