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RecruitingPhase 4NCT06690164

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

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

Sponsor

National University Hospital, Singapore

Enrollment

78 participants

Start Date

Jun 12, 2025

Study Type

INTERVENTIONAL

Conditions

Metabolite

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

Eligibility

Min Age: 21 YearsMax Age: 75 Years

Inclusion Criteria5

  • Males between 21 and 75 years old or females between 50 and 75 years old
  • No contraindications to the use of Atorvastatin amp; Omeprazole.
  • Ability to comply with study requirements eg administer Atorvastatin and Omeprazole once daily and return for follow-up 1 month later.
  • Capable of understanding the study requirements and provide informed written consent to participate.
  • Have not taken any statins or proton pump inhibitors in the past 30 days.

Exclusion Criteria8

  • Women of child-bearing age (<50 years old)
  • Pregnancy / Planning to conceive or breast-feeding
  • Current or recent history of liver disease / renal impairment / myopathy / rhabdomyolysis
  • Recent history of alcohol or drug abuse
  • Concurrent use of other drugs that may interact with Atorvastatin, Omeprazole eg clopidogrel
  • Acute infection or illness
  • Allergy to any statins or proton pump inhibitors
  • Medical condition(s) that might compromise safety or successful completion of study

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Interventions

DRUGAtorvastatin 40mg Tablet

once a day for 30 days

DRUGOmeprazole 20mg Capsule

once a day for 30 days

Locations(1)

National University of Singapore (NUS) MD6 Level 8

Singapore, Singapore

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NCT06690164