Efficacy and Safety Evaluation of the New Association on Fixed Dose of Olmesartan + Chlorthalidone, Produced by EMS S.A,in Arterial Hypertension Control
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 入组人数
- 261
- 主要终点
- Efficacy of essential hypertension control based on the reduction of systolic blood pressure at the end of the study.
研究概览
简要总结
The purpose of this study is to evaluate the non-inferiority clinical efficacy of two different drug associations in the essential hypertension control.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Consent of the patient;
- •Participants with decompensated essential hypertension, classified into stage 1 (with high or very high cardiovascular risk), stage 2 or stage 3 according to the Brazilian Society of Cardiology (2010), who have never been treated and have indication for drug combination treatment.
- •Obs: The diagnosis may be established by previous evaluation of two blood pressure measures ≥ 140/90 mmHg, with two months difference between measurements
排除标准
- •Patients with any clinically significant disease that in the investigator is opinion can not participate in the study;
- •Secondary hypertension diagnosis or blood pressure above 190x100 mmHg in the screening/randomization visit;
- •Morbid obesity or immunocompromised patients;
- •Participants with greater than 10 mmHg difference in the measurements of systolic or diastolic blood pressure between the two arms;
- •Participants who do not have the two upper limbs;
- •Participants with important electrocardiographic changes;
- •Creatinine clearance - less than 60 mL /min;
- •History of hypertensive emergencies and cardiovascular and / or moderate to severe cerebrovascular events in the past 6 months;
- •Microalbuminuria in urine sample greater than 30 mg/g;
- •Patients with history of hypersensitivity to any of the formula compounds;
- •Pregnancy or risk of pregnancy and lactating patients;
- •Participation in clinical trial in the year prior to this study.
研究组 & 干预措施
Test 1: Olmesartan + Chlorthalidone
The patients will take 1 tablet (Olmesartan medoxomil 20 mg + Chlorthalidone 12,5 mg) a day, in the morning.
干预措施: Olmesartan Medoxomil 20mg + Chlorthalidone 12,5mg (Drug)
Test 2: Olmesartan + Chlorthalidone
The patients will take 1 tablet (Olmesartan medoxomil 20 mg + Chlorthalidone 25 mg) a day, in the morning.
干预措施: Olmesartan medoxomil 20mg + Chlortalidone 25mg (Drug)
Comparator: Benicar HCT®
The patients will take 1 tablet (Olmesartan 20 mg + Hydrochlorothiazide 12,5 mg) a day, in the morning.
干预措施: Olmesartan 20mg + hydrochlorothiazide 12,5mg (Drug)
结局指标
主要结局
Efficacy of essential hypertension control based on the reduction of systolic blood pressure at the end of the study.
时间窗: 60 days
次要结局
- Safety will be evaluated by the occurrences of adverse events.(9 weeks)