Clinical Trial

Study on the Effect of Atorvastatin Co-administered With Omeprazole on Statin Lactone

Study acronym: SEACOL
Recruiting Phase 4
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Record status
This record was last updated July 2, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
Summary
This is a 2-arm, prospective, randomized, parallel-group, open-label, longitudinal study that lasts 30 days for each study participant. This study aims to investigate the effect of co-administration of Omeprazole with Atorvastatin versus Atorvastatin monotherapy on atorvastatin lactone level. Primary endpoint: Higher statin lactone level in intervention arm after 30 days. Secondary endpoints: Higher hs-CRP in intervention arm Lipid panel Incidence of adverse drug side effects (e.g. muscle-related or elevated LFTs
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-11-13.
Status change: Not Yet Recruiting → Recruiting 2025-06-27
Trial Details
NCT Number NCT06690164
Lead Sponsor National University Hospital, Singapore
Conditions Metabolite
Enrollment 78 participants
Start Date 2025-06-12
Primary Completion 2025-12 (estimated)
Study Completion 2026-06 (estimated)
Updated on ClinicalTrials.gov 2025-07-02