ATORVASTATIN for Bile acid diarrhoea

Inclusion criteria

• {"criterion_text":"- Confirmed moderate-severe bile acid diarrhoea with a SeHCAT test result of ≤ 10 %"}

Exclusion criteria

• {"criterion_text":"- 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"}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Measured as the ratio of geometric mean concentration of 7alpha-Hydroxy-4-cholesten-3-on (C4) at the end of the 80 mg atorvastatin treatment period versus at the end of the placebo treatment period."}

Secondary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Difference in mean C4 concentration (µg/L) at end of 80 mg atorvastatin period versus end of placebo period."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Difference in mean daily stools during last week of treatment periods, assessed by 7-day stool diary."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Difference in mean daily watery stools (Bristol Stool Chart scores 6 or 7) during last week of treatment periods, assessed by 7-day stool diary."}

Denmark

Earliest CTIS Part Ii Submission Date

23-05-2025

Latest Decision Or Authorization Date

04-06-2025

Processing Time Days

12

Number Of Sites

1

Number Of Participants

20

Primary sponsor

Full Name

Gentofte Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark