A Phase III, Randomized, Double-blind, Double-dummy, Active-controlled, Multicenter, Efficacy and Safety Study of a New Fixed-dose Combination of an Angiotensin Receptor Blocker and a Thiazide Diuretic for the Treatment of Essential (primary) Arterial Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 292
- 试验地点
- 1
- 主要终点
- Mean change in SBP in the sitting position at medical office at week 8 after randomization from baseline
研究概览
简要总结
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.
详细描述
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 (olmesartan 40 mg + hydrochlorothiazide 25 mg) in individuals with stage 2 primary arterial hypertension (SBP ≥ 160 ≤ 179 mm Hg or DBP ≥ 100 ≤ 109 mm Hg). This study will be used to support the registration of the new FDC of Eurofarma Laboratórios S.A.
The randomized treatment period aims to demonstrate the non-inferiority of the new combination compared to its comparator on the SBP in patients with SAH in 8 weeks of treatment after randomization.
Throughout the study, the participant must attend to four (04) in-person visits to the research site, being one Screening Visit (VS/V1) throughout the run-in period, one Randomization Visit (VR/V2), one follow-up visit after four (04) weeks (V3), and one Final Visit (VF/V4) after eight (08) weeks of randomized treatment, this being the visit to assess the primary endpoint of the study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Compliance with run-in treatment ≥ 80% and ≤ 120%.
排除标准
- •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).
- •Concomitant presence of Coronary Artery Disease, Congestive Heart Failure, Liver Failure and/or Chronic Kidney Disease stage IV or V.
- •History of hypertensive emergencies in the last 6 months.
- •Moderate to severe cardiovascular (acute myocardial infarction or unstable angina, unstable or life-threatening arrhythmia) and/or cerebrovascular events within the last 6 months or any other disorder that in the opinion of the investigator excludes the participant from the study.
- •Participant who is unwilling to switch from hypertension treatment to study medications.
- •12-lead electrocardiogram (ECG) with any clinically significant abnormality.
- •Drug or alcohol abuse in the last 2 years.
- •Allergic or hypersensitivity reactions to angiotensin II receptor blockers, thiazide diuretics or medication excipients.
研究组 & 干预措施
N0877
in the test group will be required to take 1 tablet of the test drug N0877. 1 tablet a day for 56 days +/- 4 days.
干预措施: N0877 (Drug)
Benicar HCT®
in the test group will be required to take 1 tablet of the Benicar HCT®. 1 tablet a day for 56 days +/- 4 days.
干预措施: Benicar HCT ® Tablets 40 mg/25 mg (Drug)
结局指标
主要结局
Mean change in SBP in the sitting position at medical office at week 8 after randomization from baseline
时间窗: 8 weeks
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.
次要结局
未报告次要终点