Bile acid diarrhoea
Conditions
Brief summary
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.
Detailed description
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
Interventions
DRUGPLACEBO
Sponsors
Gentofte Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Denmark
Outcome results
None listed