Boryung Pharmaceutical Co., Ltd
Seoul, South Korea
NCT Number: NCT03991442
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
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Notify Me19 year and older
All sexes
Interventional
Phase 3
Seoul, South Korea
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
1.Voluntarily provided a written consent to participate in this clinical study 2.19 years old or above Koreans living in Korea 3.Patients with uncontrolled essential hypertension at screening time(Visit 1)
Exclusion criteria
Active Comparator: a fixed dose combination of Fimasartan/Amlodipine or placebo
Other names: BR1010 or placebo
Time frame: 8weeks from Baseline Visit
The change of sitting systolic blood pressure
Time frame: 2weeks and 4weeks from Baseline Visit
The change of sitting systolic blood pressure
Time frame: 2weeks, 4weeks and 8weeks from Baseline Visit
The change of sitting systolic blood pressure and sitting diastolic blood pressure
Time frame: 2weeks, 4weeks and 8weeks from Baseline Visit
The ratio of subjects who get normalized blood pressure
Time frame: 2weeks, 4weeks and 8weeks from Baseline Visit
Response Rate
Boryung Pharmaceutical Co., Ltd
Industry
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
Acronym: FINAL
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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