跳至主要内容
临床试验/NCT00617877
NCT00617877已完成不适用

Pharmacogenetic of the Antihypertensive Response to the Angiotensin II Blockers in Monotherapy or Associated to Hydrochlorothiazide

Merck Sharp & Dohme LLC0 个研究点目标入组 800 人开始时间: 2005年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
800
主要终点
Blood pressure reduction with reference to genetic polymorphisms.

研究概览

简要总结

The purpose of this study is to evaluate the antihypertensive response of treatment with losartan with reference to genetic polymorphisms.

研究设计

研究类型
Interventional
分配方式
Non Randomized
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 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Both gender less than 60 years old, with mild-moderate hypertension (SBP greater than and DBP equal or greater than 90 mmhg, BP < 180/110)
  • Never treated for hypertension or who have taken antihypertensive agents sporadically (not more than 15 days total therapy) but not in the 30 days prior to the first visit
  • Patient in therapeutic wash out for 6 months
  • Patient is asymptomatic, absence of significant concomitant diseases, except for non-familial hypercholesterolemia, absence of systemic diseases
  • Women with menopause not treated with hormone replacement therapy or women of reproductive age who do not make use of estro-progestagen agents but who use another safe contraceptive method
  • BMI < 30 for men and < 28 for women

排除标准

  • Secondary or malignant hypertension, Na <130 mmol/l, K >5,5 mmol/l, or < 3,0 mmol/l
  • Cardiac disease such as ischemic, HF, arrhythmia, cardiac surgery
  • Pregnant, breast feeding
  • History of nephropathy, metabolic disease, liver disease
  • Alcohol or drug abuse
  • History of angioedema
  • Has a known hypersensibility to study drug(s)

研究组 & 干预措施

1

Experimental

Losartan 50 mg/day for 4 weeks, then doubled to losartan 100 mg/day in case of BP more than 140/90 mm Hg. HCTZ 25 mg will be added at week 8 if BP is more than 140/90 mm Hg. This last regimen will be continued until the end of the study (visit 9-week 48).

干预措施: losartan potassium (Drug)

结局指标

主要结局

Blood pressure reduction with reference to genetic polymorphisms.

时间窗: Over 1 Year

次要结局

未报告次要终点

研究者

申办方类型
Industry

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