A Phase 3 interventional study of Fimasartan and Amlodipine and Fimasartan in Essential Hypertension, sponsored by Boryung Pharmaceutical Co., Ltd. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-07-27.
Sponsored by Boryung Pharmaceutical Co., Ltd · Phase 3, Interventional, and Treatment
The aim of this study is to ensure the superiority of Fimasartan/Amlodipine combination in hypotensive effect after 8 weeks of treatment over Fimasartan monotherapy in patients with hypertension who have no response to Fimasartan 60mg monotherapy.
6,689 studies on the registry are indexed under Hypertension; 964 are open to participants now.
This study's enrollment of 143 is above the median of 90 across 4,994 interventional studies indexed under Hypertension.
Browse Hypertension studies →Boryung Pharmaceutical Co., Ltd is the lead sponsor of 139 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Combination of Fimasartan and Amlodipine
Drug: Fimasartan and Amlodipine
Fimasartan Monotherapy
Drug: Fimasartan
Change of Sitting Systolic Blood Pressure(SiSBP) at week 8 of Investigational Product(IP) Administration from the Baseline
To compare the difference of Mean Systolic Blood Pressure at 8 weeks from baseline visit
Time frame: 8 weeks from Baseline Visit
Change of Sitting Systolic Blood Pressure(SiSBP) at week 4 of Investigational Product(IP) Administration from the Baseline
Time frame: 4 weeks from Baseline Visit
Changes of Sitting Diastolic Blood Pressure(SiDBP) at week 4 and 8 of Investigational Product(IP) Administration from the Baseline
Time frame: 4 and 8 weeks from Baseline Visit
Response rate of the Blood Pressure at week 8 of Investigational Product(IP) Administration
Time frame: 8 weeks from Baseline Visit
The Normalization ratio of Blood Pressure at week 8 of Investigational Product(IP) Administration
Time frame: 8 weeks from Baseline Visit
Adverse Events
Time frame: 12 weeks from Screening Visit
Adverse Changes in Laboratory Test Results
Time frame: 12 weeks from Screening Visit
Adverse Changes in Electrocardiography (ECG)
Time frame: 12 weeks from Screening Visit
This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Boryung Pharmaceutical Co., Ltd