Effect of taking omeprazole with atorvastatin on atorvastatin lactone levels
Official title: Study on the Effect of Atorvastatin Co-administered With Omeprazole on Statin Lactone (SEACOL)
Run by National University Hospital, Singapore · NCT06690164 · Data updated 2026-11-12
For adults on atorvastatin, this 30-day randomized test will see if adding omeprazole raises levels of atorvastatin lactone.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 21 Years to 75 Years |
| Sex | All |
| Enrollment | 78 (estimated) |
| Sponsor | National University Hospital, Singapore Academic / other |
| Locations | 1 site (Singapore) |
| Status | Recruiting |
| Started | June 12, 2025 |
| Main results expected | December 2025 |
| Study ends | June 2026 |
| Registry record updated | July 2, 2025 |
| Trial ID | NCT06690164 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults who meet the age and sex criteria (men 21–75, women 50–75), have no contraindications to atorvastatin or omeprazole, have not taken statins or PPIs in the past 30 days, and can take daily medication and return for a one-month visit.
✕Probably not a fit
Patients with recent liver, kidney, or muscle disease, pregnant or breastfeeding women, those taking interacting medications, or anyone unable to follow study procedures are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a 30-day, two-arm, randomized, open-label, parallel-group study comparing atorvastatin 40 mg alone versus atorvastatin 40 mg plus omeprazole 20 mg daily. Eligible adults (men 21–75, women 50–75) who have not used statins or PPIs in the past 30 days are enrolled and followed for one month. The primary outcome is the difference in atorvastatin lactone concentration after 30 days; secondary measures include hs-CRP, lipid panel changes, and incidence of adverse drug effects such as muscle symptoms or elevated liver tests. Visits include screening and consent, baseline dosing, and a 30-day follow-up with blood draws and safety monitoring.
Why it matters
Potential benefit: If co-administration raises atorvastatin lactone, the finding could help clinicians avoid harmful drug interactions or adjust treatment to reduce side effects.
How similar studies have gone: PPIs and statins have known drug–drug interaction reports, but direct evidence on omeprazole specifically increasing atorvastatin lactone levels is limited, so this question is only partially explored.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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National University of Singapore (NUS) MD6 Level 8
Singapore, Singapore Recruiting
Study contacts
- Study coordinator: Junietta Lim, Bachelor of Science (Pharmacy)
- Email: seacolnus@gmail.com
- Phone: +65 86136595
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.