A Phase 3 interventional study of Fimasartan/Amlodipine, Rosuvastatin and Fimasartan/Amlodipine in Essential Hypertension and Dyslipidemia, sponsored by Boryung Pharmaceutical Co., Ltd. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-06-10.
Sponsored by Boryung Pharmaceutical Co., Ltd · Phase 3, Interventional, and Treatment
The objective of this clinical study is to evaluate the efficacy and safety by comparing the fimasartan/amlodipine/rosuvastatin treatment group to the fimasartan/amlodipine treatment group and the fimasartan/rosuvastatin treatment group respectively at Week 8 in patients with essential hypertension and dyslipidemia who fail to respond to the fimasartan monotherapy.
6,689 studies on the registry are indexed under Hypertension; 964 are open to participants now.
This study's enrollment of 138 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:
Co-administration of a fixed dose combination of Fimasartan/Amlodipine and Rosuvastatin
Drug: Fimasartan/Amlodipine, Rosuvastatin
a fixed dose combination of Fimasartan/Amlodipine
Drug: Fimasartan/Amlodipine
Co-administration of Fimasartan and Rosuvastatin
Drug: Fimasartan, Rosuvastatin
"A fixed dose combination tablet of Fimasartan and Amlodipine" and "Rosuvastatin" will be administrated once daily on treatment period.
"A fixed dose combination tablet of Fimasartan and Amlodipine" will be administrated once daily on treatment period.
"Fimasartan" and "Rosuvastatin" will be administrated once daily on treatment period.
LDL-C
The percent change in LDL-C from baseline in the test group at Week 8 compared to the fimasartan 60 mg/amlodipine 10 mg combination treatment group
Time frame: 8weeks from Baseline Visit
Sitting systolic blood pressure(SiSBP)
The change in Sitting systolic blood pressure(SiSBP) from baseline in the test group at Week 8 compared to the fimasartan 60 mg and rosuvastatin 20 mg concomitant treatment group
Time frame: 8weeks from Baseline Visit
Sitting systolic blood pressure(SiSBP)
The change in Sitting systolic blood pressure(SiSBP) from baseline in the test group at Week 8 compared to the fimasartan 60 mg/amlodipine 10 mg combination treatment group
Time frame: 8weeks from Baseline Visit
LDL-C
The percent change in LDL-C from baseline in the test group at Week 8 compared to the fimasartan 60 mg and rosuvastatin 20 mg concomitant treatment group
Time frame: 8weeks from Baseline Visit
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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Boryung Pharmaceutical Co., Ltd