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ACTIVE NOT RECRUITING Phase 3

Multi-Center Study of the Effects of Simvastatin on Hepatic Decompensation and Death in Subjects Presenting With High-Risk Compensated Cirrhosis

NCT03654053 · View on ClinicalTrials.gov ↗

Study Summary

This phase III, randomized, double-blind, placebo-controlled, multi-center study seeks to test whether simvastatin, a statin usually used to lower cholesterol to prevent heart problems and strokes, can lower the risk of hepatic decompensation (developing symptoms of cirrhosis) in U.S. Veterans who have compensated cirrhosis (the liver is scarred and damaged but there are no symptoms). The study will also explore how changes or differences in genes effect the safety and effectiveness of using statins and how the use of statins affects quality of life.

Conditions Studied

Interventions

  • DRUG Simvastatin 40mg
  • DRUG Placebo Oral Tablet

Study Locations (11)

New York

  • Brooklyn Campus of the VA NY Harbor Healthcare System, Brooklyn, NY — Brooklyn
  • James J. Peters VA Medical Center, Bronx, NY — The Bronx

Pennsylvania

  • Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA — Philadelphia
  • Philadelphia MultiService Center, Philadelphia, PA — Philadelphia

California

  • San Francisco VA Medical Center, San Francisco, CA — San Francisco

Connecticut

  • VA Connecticut Healthcare System West Haven Campus, West Haven, CT — West Haven

Kentucky

  • Robley Rex VA Medical Center, Louisville, KY — Louisville

Massachusetts

  • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA — Boston

Texas

  • Michael E. DeBakey VA Medical Center, Houston, TX — Houston

Virginia

  • Hunter Holmes McGuire VA Medical Center, Richmond, VA — Richmond

Trial Details

FieldValue
Enrollment Target 142 participants
Start Date 2020-10-02
Est. Completion 2026-12-31
Phase Phase 3

Sponsor

VA Office of Research and Development

1,863 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03654053

The ClinicalTrials.gov registry entry for NCT03654053 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 142 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,863 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Cirrhosis appearing as the primary indexed condition, and to 2 interventions — of which Simvastatin 40mg is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03654053 reports 11 study locations spanning 9 distinct geographic areas — top geographies include New York, Pennsylvania, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03654053 about?

NCT03654053 is a clinical study titled "Multi-Center Study of the Effects of Simvastatin on Hepatic Decompensation and Death in Subjects Presenting With High-Risk Compensated Cirrhosis". This phase III, randomized, double-blind, placebo-controlled, multi-center study seeks to test whether simvastatin, a statin usually used to lower cholesterol to prevent heart problems and strokes, can lower the risk of hepatic decompensation (developing symptoms of cirrhosis) in U.S. Veterans who h...

What is the current status of trial NCT03654053?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 142 participants. The study started on 2020-10-02. Estimated completion is 2026-12-31.

What conditions does trial NCT03654053 study?

This clinical trial studies the following conditions: Cirrhosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03654053?

The interventions under investigation include: Simvastatin 40mg (DRUG), Placebo Oral Tablet (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03654053?

This trial is sponsored by VA Office of Research and Development, which has 1,863 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03654053 being conducted?

This trial has 11 study locations across California, Connecticut, Kentucky, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial