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临床试验/NCT01074281
NCT01074281已完成不适用

Examination of Patients With Isolated Systolic Hypertonia (ISH) Under Therapy With ENEAS®.

Merck KGaA, Darmstadt, Germany0 个研究点目标入组 2,065 人开始时间: 2008年6月最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
2,065
主要终点
Achievement of target BP value of ≤ 140 mmHg

研究概览

简要总结

This non interventional, multicentric, uncontrolled, prospective, observational study was planned to observe the course of disease in subjects with ISH, who were treated with Eneas.

详细描述

Isolated systolic hypertonia is an autonomous form of the hypertonia, which in 73% of cases develops from a normal blood pressure (BP) situation. A strict BP control is especially important in older people, since the incidence of the ISH also increases with increasing age. This can be attributed to the elasticity of the vessels reducing with the age. Systolic Hypertension in Elderly Program (SHEP) study has shown ISH to be an independent cardiovascular risk factor.

Eneas is a combination of angiotensin converting enzyme (ACE) inhibitor enalapril maleate (10 mg) and the calcium antagonist nitrendipine (20 mg). Irrespective of the fact as shown in different studies, that calcium-antagonists as also ACE inhibitors have an especially distinctive potential for the degeneration of a left-ventricular hypertrophy (LVH). Examinations like the SYST-EUR-study has demonstrated the high therapeutic potential of the combination of nitrendipine and enalapril in older hypertonia subjects. It was proven in this multicentric, double-blind, randomised and placebo controlled study, that when the additional dose of enalapril (and if necessary diuretics was administered) in subjects with ISH above 60 years under treatment with nitrendipine and in case of not sufficient lowering of BP, the total incidence of cardiac events (heart failure, ischaemic heart disease and sudden heart fall) was reduced by 26% within two years of treatment. As part of the SYST-EUR study, a reduction of the incidence of vascular dementia by 50% was documented in the so-called "Vascular Dementia Project" with standardised psychometric measuring system. This effect was probably attributed not alone to the lowering of BP, but also to the additive ZNS-protective effects of nitrendipine and enalapril.

OBJECTIVES

Primary objective:

  • To observe the course of disease in subjects with ISH, who were treated with Eneas. In this case, particular attention was given to achievement of target value in the lowering of the systolic BP value (< 140 mmHg) within a 6 month treatment time period.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects with ISH ≥ 140 / < 90 mmHg
  • Subjects who declares his willingness for the participation in the examination
  • Subjects aged ≥ 50 years

排除标准

  • Subjects who are contraindicated for Eneas

结局指标

主要结局

Achievement of target BP value of ≤ 140 mmHg

时间窗: 6 months

次要结局

  • Recording of systolic and diastolic BP(6 months)
  • Recording of the concurrent treatments(6 months)
  • Side-effects(6 months)

研究者

申办方类型
Industry
责任方
Sponsor

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