Seoul National University Hospital
Seoul, 110-744, South Korea
NCT Number: NCT01878201
The purpose of this study is to Evaluate the Antihypertensive efficacy of Fimasartan 30 mg during 24 hours in Patients with Mild to Moderate Essential Hypertension
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Notify Me20 year–70 year
All sexes
Interventional
Phase 2
Seoul, 110-744, South Korea
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Fimasartan 30 mg
Other names: Kanarb
Valsartan 80 mg
Other names: Diovan
Time frame: 8 weeks from baseline visit
To compare the difference of Mean Systolic Blood Pressure during 24 hours at 8 weeks from baseline visit
Time frame: 8 weeks from baseline visit
To compare the difference of Mean Diastolic Blood Pressure during 24 hours at 8 weeks from baseline visit
Time frame: 8 weeks from baseline visit
To compare the difference of Diastolic Blood pressure and Systolic Blood pressure during daytime or nighttime at 8 weeks from baseline visit
Time frame: 8 weeks from baseline visit
To compare the difference of Sitting Diastolic Blood pressure and Systolic Blood pressure at 8 weeks from baseline visit
Time frame: 8 weeks from baseline visit
Trough-to-peak ratio of systolic blood pressure and diastolic blood pressure measured by ABP(Ambulatory Blood Pressure) monitor
Time frame: 8 weeks from baseline visit
Smoothness index of systolic blood pressure and diastolic blood pressure measured by ABP monitor
Time frame: about 10~11weeks from placebo run-in visit
Adverse evnt(AE)s are collected as a safety measure. All AEs are arranged based on severity, relevance to the investigational drug and serious adverse event each.
Time frame: about 10~11weeks from screening visit
Adverse changes in laboratory test results are collected as a safety measure. As a continuous data group for each test visit, adverse changes in laboratory test results present descriptive statistics (mean, standard deviation, minimum, maximum, etc.)
Time frame: about 10~11weeks from screening visit
Adverse changes in ECG are collected as a safety measure. As a categorical data, adverse changes in ECG present frequency and percentage for each category.
Boryung Pharmaceutical Co., Ltd
Industry
A Randomized, Double-blind, Valsartan 80 Mg-Referenced, Parallel Grouped, Therapeutic Exploratory Clinical Study to Evaluate the Antihypertensive Efficacy of Fimasartan 30 mg During 24 Hours in Patients With Mild to Moderate Essential Hypertension
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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