NCT01620788暂停3 期
Randomized, Phase 3, Multicenter, Open Label, Evaluating the Effect of the Treatment of Indapamide 1.5mg/Losartan 50mg and Indapamide 1.5mg/Losartan 100mg, Compared With Hyzaar® in the Treatment of Hypertension
EMS1 个研究点 分布在 1 个国家目标入组 636 人开始时间: 2019年11月27日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 发起方
- 入组人数
- 636
- 试验地点
- 1
- 主要终点
- Changes in systemic blood pressure measurements after 12 weeks
研究概览
简要总结
The purpose of this study is to evaluate the clinical efficacy of indapamide 1.5mg / losartan 50mg and indapamide 1.5mg / losartan 100mg on reduction of blood pressure.
详细描述
- open label,randomized, multicenter
- Experiment duration: 12 weeks.
- 05 visits (day 0 - randomization), (day 1 - 2 weeks pos-randomization), (day 2 - 4 weeks pos-randomization), (day 3 - 8 weeks pos-randomization) and (day 4 - 12 weeks pos-randomization).
- evaluate the efficacy of a medication associated with two antihypertensive agents in two fixed doses compared to the Hyzaar® in patients with hypertension
- Adverse events evaluation
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
- None
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
- •Adults male or female aged ≥ 18 years old;
- •Patients with a diagnosis of Hypertension (defined by the medical investigator) treated with monotherapy or at least two blood pressure measurements ≥ 140/90, in a sitting position with a 5' interval between measurements,
- •Patients with normal lab tests results in the last six months or that the investigator consider not clinically significant,
- •Patient who accept the discontinuation of previous hypertension therapy.
排除标准
- •Patients with blood pressure ≥ 180/100 mmHg;
- •Patients with uncontrolled hypertension (≥ 140/90 mmHg) treated with thiazide diuretics;
- •Presence of concomitant coronary artery disease, congestive heart failure, diabetes and renal failure (creatinine> 1.5 mg / dL);
- •Patients with hypo or hyperkalemia (serum potassium outside normal range);
- •Patients with ALT greater than 2.5 the upper limit of normal or active liver disease;
- •Pregnant women, or women in childbearing age who are not in use effective contraception or intending to become pregnant during the study period;
- •Patients on drug or alcohol abuse in the last two years;
- •Patients with secondary hypertension (renovascular disease, pheochromocytoma, Cushing's syndrome);
- •Patients with allergic reactions or hypersensitivity to ACE inhibitors, diuretics or medications containing sulfa and / or any excipients of formulation;
- •Refusal or inability to provide the Informed Consent Term.;
- •Refusal to discontinue the anti-hypertensive medication.
- •Patients at the discretion of the investigator does not have indication for discontinuing the current medications;
研究组 & 干预措施
Indapamide 1.5mg / Losartan 50mg
Experimental
干预措施: Indapamide / Losartan (Drug)
Indapamide 1.5mg / Losartan 100mg
Experimental
干预措施: Indapamide / Losartan (Drug)
Hyzaar® (Losartan 50mg/Hydrochlorothiazide12,5mg)
Active Comparator
干预措施: Hyzaar® (Drug)
Hyzaar® (Losartan 100mg/Hydrochlorothiazide 25mg)
Active Comparator
干预措施: Hyzaar® (Drug)
结局指标
主要结局
Changes in systemic blood pressure measurements after 12 weeks
时间窗: 12 weeks
次要结局
- Safety Will be Evaluated by the Adverse Events Occurrences(12 weeks)
研究者
研究点 (1)
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