NCT03991442

BR1010 in Patients With Essential Hypertension Patients Who do Not Adequately Respond to Fimasartan/Amlodipine Combination

A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of BR1010 in Essential Hypertension Patients Who do Not Adequately Respond to Fimasartan/Amlodipine Combination

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 257 (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 the BR1010 treatment group to the fimasartan/amlodipine treatment group at Week 8 in patients with essential hypertension who do not adequately respond to Fimasartan/Amlodipine combination

Conditions

• Essential Hypertension

Interventions

Type	Name	Description
DRUG	Fimasartan/Amlodipine	Active Comparator: a fixed dose combination of Fimasartan/Amlodipine or placebo

Timeline

• Start date: 2019-06-17
• Primary completion: 2021-03-02
• Completion: 2021-03-02
• First posted: 2019-06-19
• Last updated: 2021-07-30

Locations

1 site across 1 country: South Korea