A Double-blind, Placebo Controlled, Cross-over Renal Mechanistic Trial to Assess the Effect of Adding Empagliflozin Versus Placebo on Renal Hyperfiltration on a Background of the Angiotensin Converting Enzyme Inhibitor (ACEi) Ramipril: BETWEEN Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Glomerular Filtration Rate (GFR) Under Euglycaemic Conditions After 4 Weeks of Treatment With Either Empagliflozin Added to Ramipril or Placebo Added to Ramipril.
研究概览
简要总结
This is a randomized, double-blind, double-dummy, placebo-controlled, cross over design trial with empagliflozin compared to placebo that is added to open-label ramipril.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Sequence A
Empagliflozin followed by a wash-out followed by empagliflozin matching placebo on a background of open label ramipril.
干预措施: Empagliflozin (Drug)
Sequence A
Empagliflozin followed by a wash-out followed by empagliflozin matching placebo on a background of open label ramipril.
干预措施: Placebo (matching empagliflozin) (Drug)
Sequence A
Empagliflozin followed by a wash-out followed by empagliflozin matching placebo on a background of open label ramipril.
干预措施: ramipril (Drug)
Sequence B
Empagliflozin matching placebo followed a wash-out followed by empagliflozin on a background of open label ramipril.
干预措施: Empagliflozin (Drug)
Sequence B
Empagliflozin matching placebo followed a wash-out followed by empagliflozin on a background of open label ramipril.
干预措施: Placebo (matching empagliflozin) (Drug)
Sequence B
Empagliflozin matching placebo followed a wash-out followed by empagliflozin on a background of open label ramipril.
干预措施: ramipril (Drug)
结局指标
主要结局
Glomerular Filtration Rate (GFR) Under Euglycaemic Conditions After 4 Weeks of Treatment With Either Empagliflozin Added to Ramipril or Placebo Added to Ramipril.
时间窗: At week 4 and at week 12
Glomerular filtration rate (GFR) under euglycaemic conditions after 4 weeks of treatment with either empagliflozin added to ramipril or placebo added to ramipril. The pre-specified statistical analysis was not conducted, because data are too sparse in the subgroup of hyperfilterers.
次要结局
- Filtration Status (Glomerular Filtration Rate (GFR) < 120 mL/Min/1.73m², Yes/no) After 4 Weeks of Treatment With Either Empagliflozin Added to Ramipril or Placebo Added to Ramipril(At week 4 and at week 12.)