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临床试验/NCT00687206
NCT00687206已完成4 期

Efficacy and Safety of Valsartan 160 mg Plus Hydrochlorothiazide 25 mg Once a Day in Patients With Slight Hypertension and Target Organ Damage

Federico II University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2008年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
The aim of this study is to assess if an early and adequate therapy could bring to a better pressure control (even during physical activity) and a regression of organ damage assessed by bicycle stress test and mono-bidimensional echocardiography.

研究概览

简要总结

Patients with slight increase in blood pressure levels have an increased cardiovascular risk. In particular this has been demonstrated also in subjects with high-normal blood pressure in whom an exaggerated blood pressure increase, during exercise, and structural left ventricular abnormalities have been shown. On the other hand, the last American and European guidelines for management of hypertension recommend more aggressive treatment in young-middle aged subjects to achieve a better control of cardiovascular risk due to blood pressure increase. In agreement with these recommendations the investigators share the idea that a good blood pressure control should be achieved not only at rest, but also during psycho-physical stress conditions that frequently occur during daily life. On this basis, the investigators decided to evaluate the efficacy and tolerability of the association of valsartan and hydrochlorothiazide (160 an 25 mg daily, respectively) in patients with high-normal blood pressure and first degree arterial hypertension with evidence of organ damage.

The aim of this study is to assess if an early and adequate therapy could bring to a better pressure control (even during physical activity) and a regression of organ damage without interfering with metabolism and erectile function

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Aged 18-65
  • Gender Males
  • High-normal blood pressure (130-139 mmHg or 85-89 mmHg)
  • First degree hypertension (140-159 mmHg or 90-99 mmHg)
  • Cardiac remodeling (left ventricular concentric hypertrophy

排除标准

  • Coronary artery disease
  • Secondary hypertension
  • Diabetes mellitus
  • Incapacity to perform ergometry test
  • Anemia (Hb < 12.5g/dL)
  • Cardiac valve disease
  • Arrhythmia

研究组 & 干预措施

1

Experimental

干预措施: Valsartan 160mg plus HCT 25mg (Drug)

结局指标

主要结局

The aim of this study is to assess if an early and adequate therapy could bring to a better pressure control (even during physical activity) and a regression of organ damage assessed by bicycle stress test and mono-bidimensional echocardiography.

时间窗: 3 and 6 months

次要结局

  • Effects of Valsartan 160mg / HCT 25mg on metabolism and erectile function(3 and 6 months)

研究者

发起方
Federico II University
申办方类型
Other

研究点 (1)

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