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

NCT06690164 | Recruiting Phase 4

• 1 other identifier: 2023/00947
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

atorvastatin; atorvastatin lactone; omeprazole

Outcome Measures

Primary Outcomes (1)

• Higher statin lactone level in intervention arm after 30 days

  Measure and compare statin lactone levels in intervention arm 1 and control arm 2

  30 days

Secondary Outcomes (3)

• Higher hs-CRP in intervention arm after 30 days

  30 days

• Lipid panel

  30 days

• Incidence of adverse drug side effects

  30 days

Study Arms (2)

Intervention arm 1

EXPERIMENTAL

Atorvastatin 40mg once a day + Omeprazole 20mg once a day, both drugs to be taken for 30 days.

Drug: Atorvastatin 40mg Tablet; Drug: Omeprazole 20mg Capsule

Control arm 2

ACTIVE COMPARATOR

Atorvastatin 40mg once a day to be taken for 30 days.

Drug: Atorvastatin 40mg Tablet

Interventions

Atorvastatin 40mg Tablet DRUG

once a day for 30 days

Control arm 2; Intervention arm 1

Omeprazole 20mg Capsule DRUG

once a day for 30 days

Intervention arm 1

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University of Singapore (NUS) MD6 Level 8

Singapore, Singapore

RECRUITING

MeSH Terms

Interventions

Atorvastatin; Omeprazole

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Junietta Lim, Bachelor of Science (Pharmacy)

CONTACT

+65 86136595; seacolnus@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2-arm, parallel group assignment: Arm 1: Atorvastatin 40mg + Omeprazole 20mg Arm 2: Atorvastatin 40mg onl

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 15, 2024
• Study Start: June 12, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 2, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)