2025-521856-47-00招募中4 期
Treatment of Bile Acid Diarrhoea with Atorvastatin (BASTA)
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Ratio of geometric mean concentration of 7alpha-Hydroxy-4-cholesten-3-on (C4) at the end of the 80 mg atorvastatin treatment period compared to the end of the placebo treatment period.
研究概览
简要总结
The current study aims to investigate whether atorvastatin treatment lowers the synthesis of bile acids, measured via the well-known bile acid synthesis marker C4, in a dose-response manner in patients with moderate-severe bile acid diarrhoea.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Confirmed moderate-severe bile acid diarrhoea with a SeHCAT test result of ≤ 10 %
排除标准
- •History of/present hepatobiliary disorder (except for simple metabolic dysfunction-associated fatty liver disease) and/or alanine aminotransferase and/or serum aspartate aminotransferase ≥ 3 times upper limit of normal
结局指标
主要结局
Ratio of geometric mean concentration of 7alpha-Hydroxy-4-cholesten-3-on (C4) at the end of the 80 mg atorvastatin treatment period compared to the end of the placebo treatment period.
Ratio of geometric mean concentration of 7alpha-Hydroxy-4-cholesten-3-on (C4) at the end of the 80 mg atorvastatin treatment period compared to the end of the placebo treatment period.
次要结局
- Difference in mean concentration of 7alpha-Hydroxy-4-cholesten-3-on (C4) in µg/L at the end of the 80 mg atorvastatin treatment period compared to the end of the placebo treatment period.
- Difference in mean daily stools during the last week of the 80 mg atorvastatin treatment period compared to the last week of the placebo treatment period as assessed by a 7-day stool diary.
- Difference in mean daily watery stools during the last week of the 80 mg atorvastatin treatment period compared to the last week of the placebo treatment period as assessed by the total watery (6 or 7 on the Bristol Stool Chart) stools in a 7-day stool diary
研究者
Center for Clinical Metabolic Research
Scientific
Gentofte Hospital
研究点 (1)
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