Reassessment of statin-associated musscle symptoms in adults with familial hypercholesterolemia: A phase IV randomized double-blinded n-of-1 crossover trial including periods with atorvastatin, placebo and no study treatment

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-521589-83-00

Enrollment

Registered

2026-05-22

Start date

Unknown

Completion date

Unknown

Last updated

2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Familial hypercholesterolaemia

Brief summary

The individual mean difference in muscular symptom intensity over the last two weeks (week 5-6) between treatment periods with atorvastatin and placebo (at least 10 units and 25% difference on a 0-100 units rating scale).

Detailed description

Area under the Receiver Operating Characteristic (ROC) curve, and diagnostic sensitivity and specificity.

Interventions

DRUGEncapsulated placebo tablets

DRUGAtorvastatin Xiromed 20 mg tablett

DRUGfilmdrasjert

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The individual mean difference in muscular symptom intensity over the last two weeks (week 5-6) between treatment periods with atorvastatin and placebo (at least 10 units and 25% difference on a 0-100 units rating scale).	—

Secondary

Measure	Time frame
Area under the Receiver Operating Characteristic (ROC) curve, and diagnostic sensitivity and specificity.	—

Outcome results

None listed

Source: EU CTIS · Data processed: May 23, 2026