NCT00843388Unknown4 期
A Randomized Doubleblind Placebo Controlled Crossover Study With Hexalacton in Patients With Type 1 Diabetes and Microalbuminuria
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 20
- 主要终点
- albuminuria, expected decrease
研究概览
简要总结
A double blind, randomized, cross over study in type 1 diabetic patients. 20 patients, age 18-65 years is treated with spironolacton (Hexalacton (R)) for 60 days followed by 60 days treatment with placebo(or opposite). Primary aim: albuminuria, an expected decrease during hexalacton treatment. Secondary aim: ambulatory blood pressure, GFR, plasma-renin, angiotensin, aldosteron.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 1 diabetes
- •age 18-80 years
- •microalbuminuria
排除标准
- •blood pressure> 160/100 mmHg
- •persistent macroalbuminuria
- •pregnancy or in risc of this
- •P-Potassium>5.7 mmol/l
- •Eplerone treatment
研究组 & 干预措施
1
Active Comparator
60 days treatment with tablet hexalacton 25 mg OD.
干预措施: Spironolacton (hexalacton(R)) (Drug)
2
Placebo Comparator
Inactive drug of 25 mg OD
干预措施: placebo tablet (Drug)
结局指标
主要结局
albuminuria, expected decrease
时间窗: 60 days
次要结局
- GFR(60 days)
- ambulatory blood pressure(60 days)
- plasma renin, angiotensin, aldosteron(60 days)
研究者
相似试验
已完成
早期 1 期
A Trial to Investigate Hyperglycemic and Hypoglycemic Excursions in Subjects With Type 1 DiabetesType 1 Diabetes Mellitus With HypoglycemiaNCT04712266Abvance Therapeutics15
已完成
1 期
A Study to Assess the Safety, Tolerability and Preliminary Efficacy of HH-120 for the Treatment of COVID-19COVID-19NCT06039163Huahui Health37
Unknown
不适用
Baclofen/Diazepam Supps for Treatment of Pelvic Floor MyalgiaPelvic Floor DyssynergiaNCT03427216Dr. John A. Thiel Medical Professional Corporation60
已完成
2 期
Out-Patient Study in Patients With Type 2 Diabetes Mellitus Who Are Taking no Diabetes Medication or Metformin OnlyDiabetes Mellitus, Type 2NCT00518115GlaxoSmithKline361
终止
2 期
Safety and Efficacy Study of A0001 in Patients With the A3243G Mitochondrial DNA Point MutationNeuromuscular DiseaseNCT01074359Penwest Pharmaceuticals Co.30