跳至主要内容
临床试验/CTRI/2021/04/032642
CTRI/2021/04/032642尚未招募2 期

A Placebo Controlled Double- Blind Randomized Control Study To Assess The Efficacy And Safety Of Oral Losartan In The Treatment Of Recessive Dystrophic Epidermolysis Bullosa

PGIMER0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
PGIMER

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 1.Recessive dystrophic epidermolysis bullosa patients regardless of sex.
  • 2.Patients of age 6 years and above
  • 3.Patients who are normotensive or hypertensive (cause other than renal stenosis)
  • 4.Patients with normal renal function, liver function and serum potassium levels.
  • 5.Patients who can give valid consent.
  • 6.Willing for monthly follow-up visits for at least 6 months.

排除标准

  • 1.Dominant dystrophic epidermolysis bullosa, epidermolysis bullosa simplex, junctional epidermolysis bullosa and kindler syndrome
  • 2.High levels of potassium in the blood.
  • 3.Hypotension (defined as age- related systolic blood pressure under the 5th percentile)
  • 4.Hypersensitivity to losartan
  • 5.Kidney impairment with eGFR less than <30ml/ min
  • 6.Renal artery stenosis.
  • 7.Deranged liver function tests.
  • 8.Patients who are HBsAg, Anti HCV and HIV positive.
  • 9.Patients who are taking medicines which are likely to cause interactions like ACE inhibitors, Rifampicin
  • 10.Current pregnancy or nursing period
  • 11.Inability to come for monthly follow up visits for 6 months
  • 12.Those who donâ??t provide consent for the study

研究者

发起方
PGIMER

相似试验