NCT00355589已完成3 期
A Randomized, Double-Blind, Multicenter, Parallel Study Evaluating the Efficacy and Safety of a Combination of Ramipril Plus Hydrochlorothiazide Versus the Component Monotherapies in Subjects With Essential Hypertension
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 试验地点
- 120
- 主要终点
- Compare the effects on sitting diastolic blood pressure of two antihypertensive drugs in combination against each antihypertensive alone after an eight week treatment period.
研究概览
简要总结
The purpose of this study is to determine if there is greater blood pressure reduction using ramipril or hydrochlorothiazide alone or ramipril and hydrochlorothiazide together.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously diagnosed, or newly diagnosed essential hypertension. Blood pressure must be within a minimum and maximum range prior to drug treatment.
排除标准
- •Inability to discontinue all prior antihypertensive medications
- •Heart failure
- •History of stroke, myocardial infarction, or chest pain within 3 years, or an abnormal heart rhythm
- •Liver or kidney disease
- •Certain drugs used to treat other conditions like an enlarged prostate gland, or arthritis
- •Allergy or reactions to certain medications used to treat high blood pressure
- •Other protocol-defined inclusion and exclusion criteria apply.
结局指标
主要结局
Compare the effects on sitting diastolic blood pressure of two antihypertensive drugs in combination against each antihypertensive alone after an eight week treatment period.
次要结局
- Compare the effect on sitting diastolic blood pressure of two antihypertensive drugs in combination taken once daily against one antihypertensive drug taken twice daily.
- Compare the effect on sitting diastolic blood pressure of a dose of an antihypertensive drug taken once daily against half of the same dose taken twice daily.
- Compare the effect on the sitting and standing blood pressure among all treatment groups.
- Compare the safety of each medication regimen stated above.
- Compare the effect on mean 24-hour diastolic blood pressure (ABPM) of the medication regimens stated above.
研究者
研究点 (120)
Loading locations...
相似试验
终止
3 期
A Study of the Effectiveness and Safety of Ramipril in the Treatment of Hypertension in Children and AdolescentsHypertensionNCT00389519Pfizer422
已完成
3 期
Fimasartan in the Senior SubjectsThe Elderly (≥ 70 Years) With Essential HypertensionNCT03246555Boryung Pharmaceutical Co., Ltd241
已完成
3 期
Efficacy and Safety of SPA100 (Fixed-dose Combination of Aliskiren/Amlodipine) in Patients With Essential HypertensionEssential HypertensionNCT01237223Novartis1,342
已完成
2 期
Study of Nifedipine GITS and Candesartan Combination Compared to Monotherapy in Patients With Essential HypertensionHypertension, EssentialNCT01303783Bayer1,381
已完成
3 期
Efficacy and Safety of Aliskiren 300mg Compared to Irbesartan 300mg and Ramipril 10 mg in the Setting of a Missed Dose for Patients With Essential Hypertension.Essential HypertensionNCT00343551Novartis654