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

Recruiting now · Phase 4

Conditions studied: Metabolite

In brief

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

Key facts

Study ID: NCT06690164
Run by: National University Hospital, Singapore
People needed: 78
Starts: 2025-06-12
Expected to finish: 2026-06-01
Last updated by the study team: 2025-07-02

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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 is running

National University of Singapore (NUS) MD6 Level 8 — Singapore, Singapore (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.