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临床试验/EUCTR2010-022138-10-IT
EUCTR2010-022138-10-IT进行中(未招募)不适用

A SINGLE-CENTRE, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY TO ASSESS SAFETY AND EFFICACY OF COMBINATION THERAPY WITH VARDENAFIL 10 mg AND TAMSULOSIN 0,4 mg IN THE TREATMENT OF MEN WITH PERSISTENT IRRITATIVE URINARY SYMPTOMS - FI.LU.VA

AZIENDA OSPEDALIERA UNIVERSITARIA CAREGGI0 个研究点开始时间: 2011年6月9日最近更新:
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
Male

入选标准

  • Age between 40 and 80 years • Men with LUTS and OAB defined by: – IPSS, flow assessment, measurement of post void residual urine – Mean urinary frequency ?8 times /24 hours.Mean number of urgency episodes, with or without urgency incontinence ?1 episode /24 hours. ? With both irritative and obstructive symptoms • Mean voided volume <400 ml as verified by the bladder diary completed prior to randomization • Qmax >5 ml/sec with a voided volume >150 ml • Evidence of a personally signed and dated informed consent
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Hypersensitivity to vardenafil or omnic • Drugs with proven or suspected incompatibility with vardenafil or omnic • Bladder failure or Neurogenic bladder • UTI / Prostatitis • LUT disease + LUT treatment • LUT surgery • Severe systemic disease • Unable to consistently and accurately complete the protocol

研究者

发起方
AZIENDA OSPEDALIERA UNIVERSITARIA CAREGGI

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