NCT02521233撤回3 期
Efficacy and Safety Evaluation of the New Association on Fixed Dose of Candesartan + Chlorthalidone, Produced by EMS S.A,in Arterial Hypertension Control
EMS0 个研究点开始时间: 2016年11月最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 主要终点
- Efficacy of essential hypertension control based on proportion of participants who achieve the therapeutic goal
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: Candesartan + Chlorthalidone
Experimental
The patients will take 1 tablet (Candesartan cilexetil 8 mg + Chlorthalidone 12,5 mg) a day, in the morning.
干预措施: Candesartan + Chlorthalidone (8mg+12,5mg) (Drug)
Test 2: Candesartan + Chlorthalidone
Experimental
The patients will take 1 tablet (Candesartan cilexetil 8 mg + Chlorthalidone 25 mg) a day, in the morning.
干预措施: Candesartan + Chlorthalidone (8 mg + 25 mg) (Drug)
Comparator: losartan+hydrochlorothiazide (Hyzaar®)
Active Comparator
he patients will take 1 tablet (Losartan 50 mg + Hydrochlorothiazide 12,5 mg) a day, in the morning.
干预措施: losartan+hydrochlorothiazide (Drug)
结局指标
主要结局
Efficacy of essential hypertension control based on proportion of participants who achieve the therapeutic goal
时间窗: 60 days
次要结局
- Safety will be evaluated by the occurrences of adverse events.(9 weeks)
研究者
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