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临床试验/NCT00541684
NCT00541684已完成3 期

A Randomized, Double-Blind, Two Arm, Parallel Group Health Assessment Study of Losartan or Atenolol in Patients With Mild to Moderate Hypertension

Organon and Co0 个研究点目标入组 143 人开始时间: 2001年7月11日最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
143
主要终点
number of sexual intercourse events in a 2-week period

研究概览

简要总结

The study will look at the effects of losartan or atenolol on frequency of sexual intercourse in subjects with newly diagnosed mild to moderate hypertension.

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
40 Years 至 49 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Newly diagnosed with mild to moderate hypertension\
  • Married male in stable heterosexual relationship
  • No prior history of sexual dysfunction
  • Satisfied with overall sex life
  • Patient's spouse is in close proximity for the study
  • Has had at least 2 but not more than 10 sexual intercourse events during the 2 week period prior to study start
  • Patient able to visit doctor in the morning of each scheduled visit
  • Able to complete the self administered health assessment questionnaire

排除标准

  • Hypertension due to cancer, history of heart or circulatory problems
  • History of mental disorder that might impair sexual function
  • History or presence of drug or alcohol abuse
  • Prior surgery for erectile dysfunction or other urological procedure
  • No penile implant or assist devices
  • History of chronic liver disease, history of diabetes
  • History of severe life-threatening diseases such as, cancer, AIDS or positive HIV test
  • Subjects with only 1 kidney
  • Mental handicap or legal incapacity

结局指标

主要结局

number of sexual intercourse events in a 2-week period

时间窗: 2 Weeks

次要结局

  • sexual functioning score and overall sexual satisfaction score after 16 weeks(16 Weeks)

研究者

申办方类型
Industry
责任方
Sponsor

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