A Phase 3 interventional study of Fimasartan 120mg and Atorvastatin 40mg in Essential Hypertension, Dyslipidemia, sponsored by Boryung Pharmaceutical Co., Ltd. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-11-05.
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/atorvastatin treatment group to the fimasartan/placebo treatment group and the placebo/atorvastatin treatment group respectively at Week 8 in patients with essential hypertension and dyslipidemia.
Exclusion Criteria:
Co-administration of a fixed dose combination of Fimasartan 120mg and Atorvastatin 40mg
Drug: Fimasartan 120mg · Drug: Atorvastatin 40mg
Co-administration of Fimasartan 120mg and Placebo for Atorvastatin 40mg
Drug: Fimasartan 120mg · Drug: Placebo for Atorvastatin 40mg
Co-administration of Atorvastatin 40mg and Placebo for Fimasartan 120mg
Drug: Atorvastatin 40mg · Drug: Placebo for Fimasartan 120mg
Fimasartan 120mg will be administrated once daily for 8 weeks treatment period
Atorvastatin 40mg will be administrated once daily for 8 weeks treatment period
Placebo for Fimasartan 120mg will be administrated once daily for 8 weeks treatment period
Placebo for Atorvastatin 40mg will be administrated once daily for 8 weeks treatment period
SiSBP
The change in Sitting systolic blood pressure(SiSBP) from baseline in the test group(Fimasartan 120mg/Atorvastatin 40mg) at Week 8 compared to the Active Comparator group 2(Atorvastatin 40mg)
Time frame: 8weeks from Baseline Visit
LDL-C
The change in LDL-C from baseline in the test group at Week 8 compared to the active comparator group 1(fimasartan 120 mg)
Time frame: 8weeks from Baseline Visit
SiSBP
The change in Sitting systolic blood pressure(SiSBP) from baseline in the test group(Fimasartan 120mg/Atorvastatin 40mg) at Week 8 compared to the Active Comparator group 1(Fimasartan 120mg)
Time frame: 8weeks from Baseline Visit
LDL-C
The change in LDL-C from baseline in the test group(Fimasartan 120mg/Atorvastatin 40mg) at Week 8 compared to the Active Comparator group 2(Atorvastatin 40mg)
Time frame: 8weeks from Baseline Visit
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Boryung Pharmaceutical Co., Ltd