MedTrace Logo

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

NCT06690164 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2025-07-02

No results posted yet for this study

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

Conditions

  • Metabolite

Interventions

DRUG

Atorvastatin 40mg Tablet

once a day for 30 days

DRUG

Omeprazole 20mg Capsule

once a day for 30 days

Sponsors & Collaborators

  • National University Hospital, Singapore

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-12
Primary Completion
2025-12-31
Completion
2026-06-30

Countries

  • Singapore

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06690164 on ClinicalTrials.gov