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

RecruitingPhase 4Ages 21 Years - 75 YearsAllNational University Hospital, Singapore
NCT06690164 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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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What it tests

  • Atorvastatin 40mg Tablet
  • Omeprazole 20mg Capsule
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Where

1 site
National University of Singapore (NUS) MD6 Level 8
Singapore, Singapore
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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