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

NCT06690164 Phase 4 RECRUITING

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

Details

Lead sponsor	National University Hospital, Singapore
Phase	Phase 4
Status	RECRUITING
Enrolment	78
Start date	2025-06-12
Completion	2026-06

Conditions

• Metabolite

Interventions

• Atorvastatin 40mg Tablet
• Omeprazole 20mg Capsule

Primary outcomes

• Higher statin lactone level in intervention arm after 30 days — 30 days
  Measure and compare statin lactone levels in intervention arm 1 and control arm 2

Countries

Singapore