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Clinical Evaluation of Simcyp-Guided Simvastatin Dosing in Patients With Liver Cirrhosis

NCT07459972 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2026-03-11

No results posted yet for this study

Summary

This prospective open-label parallel pilot clinical study evaluated the efficacy and safety of physiologically based pharmacokinetic (PBPK)-guided simvastatin dosing in Child-Pugh A and B cirrhotic patients with portal hypertension over a 3-month period. Twenty-two patients were enrolled following screening, and portal hemodynamic, laboratory, and safety parameters were assessed.

Conditions

Interventions

DRUG

Simvastatin 15 mg

Simvastatin is an HMG-CoA reductase inhibitor that improves endothelial nitric oxide bioavailability and reduces intrahepatic vascular resistance, thereby potentially lowering portal pressure.

DRUG

Simvastatin 5 mg

Simvastatin is an HMG-CoA reductase inhibitor that improves endothelial nitric oxide bioavailability and reduces intrahepatic vascular resistance, thereby potentially lowering portal pressure.

Sponsors & Collaborators

  • Kafrelsheikh University

    lead OTHER

Principal Investigators

  • Naira Galal, BSc in Pharmacy · Clinical Pharmacy Department, Faculty of Pharmacy, Kafrelsheikh University

  • Noha Mahmoud El-khodary, PhD · Clinical Pharmacy Department, Faculty of Pharmacy, Kafrelsheikh University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-15
Primary Completion
2025-03-15
Completion
2025-06-15

Countries

  • Egypt

Study Locations

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Entities

Diseases

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 NCT07459972 on ClinicalTrials.gov