The objective of this study is to confirm the noninferiority of the blood pressure lowering effect of fimasartan and evaluate its safety compared to perindopril in the elderly with essential hypertension.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
241
The treatment in this clinical study starts with fimasartan 30 mg; if blood pressure is not controlled (siSBP ≥ 140 mmHg or siDBP ≥ 90 mmHg), the dose is escalated once gradually, and then a diuretic combination is administered. The escalation of dose and administration of diuretic combination are decided after checking blood pressure 4 weeks after the administration of each investigational product.
The treatment in this clinical study starts with penrindopril 2.5 mg; if blood pressure is not controlled (siSBP ≥ 140 mmHg or siDBP ≥ 90 mmHg), the dose is escalated once gradually, and then a diuretic combination is administered. The escalation of dose and administration of diuretic combination are decided after checking blood pressure 4 weeks after the administration of each investigational product.
Seoul National University Bundang
Seoul, South Korea
Change in siSBP
Change in siSBP from baseline after the administration of the investigational product for 8 weeks
Time frame: 8 weeks
Change in siSBP
Change in siSBP from baseline at Weeks 4, 16 and 24
Time frame: Weeks 4, 16 and 24
Change in siDBP
Change in siDBP from baseline at Weeks 4, 8, 16 and 24
Time frame: Weeks 4, 8, 16 and 24
Blood pressure response rate
Blood pressure response rate (siSBP \< 140 mmHg, or decrease of △siSBP ≥ 20 mmHg after the administration for 4, 8 and 16 weeks compared to baseline) and blood pressure normalization rate after the administration of the investigational products for 4, 8 and 16 weeks(siSBP\<140mmHg and siDBP\<90mmHg)
Time frame: 4, 8 and 16 weeks
Change from baseline in the differences in standing SBP and DBP compared to their sitting measurements
Change from baseline in the differences in standing SBP and DBP compared to their sitting measurements after the administration of the investigational product for 4, 8, 16 and 24 weeks
Time frame: 4, 8, 16 and 24 weeks
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