A Double Blind, Dose Range, Placebo Controlled Study of the Effects of Rostafuroxin vs Placebo in Patients With Stable, Uncomplicated, Essential Hypertension.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 438
- 试验地点
- 1
- 主要终点
- Office Systolic Blood Pressure after 5 week of treatment
研究概览
简要总结
The purpose of this study is to verify the efficacy of Rostafuroxin in the treatment of essential hypertension and to determine the best effective dose to be administered in the general hypertensive population and in a subset of this population in which genetic patterns could be involved in the etiology of essential hypertension.
详细描述
Elevated arterial pressure is probably the most important public health problem. about 30% of the world adult population are affected by hypertension in industrialised countries. Development of a pharmacogenomic approach to the therapy of primary hypertension give new opportunities for the treatment of hypertension. This approach consists in the identification of the genetic-molecular mechanisms responsible for hypertension in a given subset of patients, and in the development of drugs able to interfere with such mechanisms, thus leading to very selective therapeutic interventions with enhanced efficacy and reduced side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with grade 1 or 2 of essential hypertension
- •Less than 3 risk factors (age > 55 if male, smoking, dyslipidemia, family history of CV disease occurring before 55 years in men and 65 in women
- •Naive patients or currently on monotherapy or one combination tablet
- •SBP between 140 and 169 mmHg
排除标准
- •Atrial fibrillation or left or right VBBB
- •Left ventricular hypertrophy
- •Significant renal or hepatic disease
- •Obesity > 30kg/m2
- •Diabetes mellitus
研究组 & 干预措施
Rostafuroxin 50 micrograms capsules
5 weeks, once a day capsule treatment of active drug or placebo, followed by a 5 weeks, once a day capsule treatment of placebo or active drug according to a cross-over design
干预措施: Rostafuroxin (Drug)
Rostafuroxin 150 micrograms capsules
5 weeks, once a day capsule treatment of active drug or placebo, followed by a 5 weeks, once a day capsule treatment of placebo or active drug according to a cross-over design
干预措施: Rostafuroxin (Drug)
Rostafuroxin 500 micrograms capsules
5 weeks, once a day capsule treatment of active drug or placebo, followed by a 5 weeks, once a day capsule treatment of placebo or active drug according to a cross-over design
干预措施: Rostafuroxin (Drug)
Rostafuroxin 1.5 mg capsules
5 weeks, once a day capsule treatment of active drug or placebo, followed by a 5 weeks, once a day capsule treatment of placebo or active drug according to a cross-over design
干预措施: Rostafuroxin (Drug)
Rostafuroxin 5 mg capsule
5 weeks, once a day capsule treatment of active drug or placebo, followed by a 5 weeks, once a day capsule treatment of placebo or active drug according to a cross-over design
干预措施: Rostafuroxin (Drug)
结局指标
主要结局
Office Systolic Blood Pressure after 5 week of treatment
时间窗: 5 weeks
次要结局
- Office Diastolic Blood Pressure(5 weeks)
- Proportion of normalised and responder patients (all visits)(5 weeks)
- 24 hours BP monitoring (through to peak ratio)(5 weeks)
- Effect on sub-populations, genetically selected(5 weeks)
- safety of the drug(monitored during all the study)