This is a phase III, non-inferiority, randomized, double-blind, double-dummy, active-controlled, multicenter study to compare the efficacy and safety of N0877 versus double combination with already established efficacy on systolic blood pressure (SBP) in the sitting position in the medical office in patients with SAH after 8 weeks of treatment.
Ability to confirm voluntary participation and agree to all purposes of the study, signing and dating the Informed Consent Form in two copies.
Age ≥ 18 years.
Medical office blood pressure with SBP ≥ 160 mm Hg or DBP ≥ 100 mm Hg without pharmacological treatment or which is not adequately controlled with monotherapy or with a combination of two drugs in which at least one of the drugs is not at the maximum dose.
Uncontrolled arterial hypertension (medical office BP with SBP ≥ 140 mm Hg or DBP ≥ 90 mm Hg) after at least two (02) weeks of run-in treatment.
Pregnant or lactating women.
Women in the reproductive age or of childbearing potential who do not agree to use a proven effective contraceptive method, unless they are surgically sterile or expressly declare themselves to be free from the risk of pregnancy because they do not engage in sexual practices or engage in them in a non-reproductive manner.
Medical office blood pressure with SBP ≥ 180 mm Hg or DBP ≥ 110 mm mmHg.
Resistant hypertension or secondary hypertension of any etiology (including renovascular disease, pheochromocytoma and Cushing's syndrome).
Parallel
N0877
Drug1 tablet of N0877 and 1 tablet of Placebo of Benicar HCT®
Benicar HCT ® Tablets 40 mg/25 mg
Drug1 tablet of Benicar HCT® and 1 tablet of Placebo of N0877
Mean change in SBP in the sitting position at medical office at week 8 after randomization from baseline
To demonstrate the non-inferiority of the N0877 to double combination with an already established profile (olmesartan 40 mg + hydrochlorothiazide 25 mg) on systolic blood pressure (SBP) in the sitting position in the medical office in patients with SAH after 8 weeks of treatment.
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