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NCT00120887 · ClinicalTrials.gov registry record · Phase 4

Lupus Atherosclerosis Prevention Study

A Phase 4 study of Systemic Lupus Erythematosus, sponsored by Johns Hopkins University.

Completed
Registry status
Phase 4
Development phase
200
Enrollment target
1
Study location

NCT00120887 is a Phase 4 study of Systemic Lupus Erythematosus that has completed, run by Johns Hopkins University. The registered enrollment target is 200 participants, below the 378-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (47% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00120887, a Phase 4 study of Systemic Lupus Erythematosus, has completed, sponsored by Johns Hopkins University.

COMPLETED
Registry status
Phase 4
Development phase
200 participants
Enrollment target
1
Study location

Study Summary

Cardiovascular disease, specifically from atherosclerosis, is the major cause of mortality in systemic lupus erythematosus (SLE) in developed countries. Coronary artery disease and stroke contribute to long-term morbidity in surviving patients. Atherosclerosis in SLE is multifactorial, with immune/inflammatory endothelial damage, traditional cardiovascular risk factors, and prothrombotic factors all playing important roles. Multiple groups have shown that hyperlipidemia is predictive of later atherosclerosis in SLE. In the general population, statins have become the drug of choice in preventing atherosclerotic events, through two mechanisms: lipid lowering that helps to prevent progression, and stabilization of plaques to prevent rupture. In the Lupus Atherosclerosis Prevention Trial we will determine if atorvastatin reduces the progression of atherosclerosis on helical computed tomography (CT) and carotid duplex. Recent work has confirmed that statins have an immunomodulatory role. This study will also determine whether statins improve clinical lupus activity or lupus serologies (anti-dsDNA and complement).

Interventions

  • DRUG Atorvastatin

Study Locations (1)

Maryland

  • Johns Hopkins Lupus Center 1830 E Monument Street, Ste 7500 - Baltimore

Trial Details

FieldValue
Enrollment Target 200 participants
Start Date 2002-04
Est. Completion 2005-12
Phase Phase 4

Sponsor

Johns Hopkins University

1,448 total trials

What the Registry Record Tells You About NCT00120887

The ClinicalTrials.gov registry entry for NCT00120887 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 378-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (47% lower). The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Systemic Lupus Erythematosus appearing as the primary indexed condition, and to 1 intervention - of which Atorvastatin is the first listed.

NCT00120887 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT00120887 about?

NCT00120887 is a clinical study titled "Lupus Atherosclerosis Prevention Study". Cardiovascular disease, specifically from atherosclerosis, is the major cause of mortality in systemic lupus erythematosus (SLE) in developed countries. Coronary artery disease and stroke contribute to long-term morbidity in surviving patients. Atherosclerosis in SLE is multifactorial, with immune/i...

What is the current status of trial NCT00120887?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 200 participants. The study started on 2002-04. Estimated completion is 2005-12.

What conditions does trial NCT00120887 study?

This clinical trial studies the following conditions: Systemic Lupus Erythematosus.

What interventions are being tested in trial NCT00120887?

The interventions under investigation include: Atorvastatin (DRUG).

Who is sponsoring clinical trial NCT00120887?

This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00120887 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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