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NCT00065806 · ClinicalTrials.gov registry record · Phase 3
Atherosclerosis Prevention in Pediatric Lupus Erythematosus (APPLE)
A Phase 3 study of Lupus Erythematosus, Systemic, sponsored by Laura Schanberg.
- Completed
- Registry status
- Phase 3
- Development phase
- 221
- Enrollment target
- 1
- Study location
NCT00065806: Completed Phase 3 study of Lupus Erythematosus, Systemic, sponsored by Laura Schanberg.
NCT00065806 is a Phase 3 study of Lupus Erythematosus, Systemic that has completed, run by Laura Schanberg. The registered enrollment target is 221 participants, above the 196-participant average among 29 other Lupus Erythematosus, Systemic trials with a reported enrollment target (13% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00065806, a Phase 3 study of Lupus Erythematosus, Systemic, has completed, sponsored by Laura Schanberg.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 221 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is: 1. To assess the efficacy of a lipid-lowering agent (atorvastatin) on the development of atherosclerosis that predisposes children with SLE to cardiovascular events in adulthood. 2. To assess the safety of intermediate-term (36 months) treatment of children and young adults with atorvastatin. 3. To further characterize the course of SLE in children and young adults, by establishing a cohort of pediatric SLE patients to be followed prospectively. 4. To establish a mechanism for conducting clinical trials in rare pediatric rheumatic diseases using the Children's Arthritis and Rheumatology Research Alliance (CARRA).
Primary Outcome
For the common carotid arterial segment, mean CIMT values were averaged across angles by side and wall to produce 4 summary variables (right common near wall mean, right common far wall mean, left common near wall mean and left common far wall mean). These summary variables were then averaged to estimate a single mean-mean common CIMT for each participant visit.
Conditions Studied
Interventions
- DRUG Atorvastatin
- DRUG Placebo atorvastatin
Study Locations (1)
North Carolina
- Duke Medical Center / Duke Clinical Research Institute - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 221 participants |
| Start Date | 2003-09 |
| Est. Completion | 2009-12 |
| Phase | Phase 3 |
What the finished NCT00065806 record still lists
NCT00065806 is an interventional study that assigns participants to a tested intervention. The registered 221 participants enrollment target is mid-sized for trials with a published cap, above the 196-participant average among 29 other Lupus Erythematosus, Systemic trials with a reported enrollment target (13% higher).
The record links to 1 condition, with Lupus Erythematosus, Systemic appearing as the primary indexed condition, and to 2 interventions - of which Atorvastatin is the first listed.
NCT00065806 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT00065806 about?
NCT00065806 is a clinical study titled "Atherosclerosis Prevention in Pediatric Lupus Erythematosus (APPLE)". The purpose of this study is: 1. To assess the efficacy of a lipid-lowering agent (atorvastatin) on the development of atherosclerosis that predisposes children with SLE to cardiovascular events in adulthood. 2. To assess the safety of intermediate-term (36 months) treatment of children and young a...
What is the current status of trial NCT00065806?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 221 participants. The study started on 2003-09. Estimated completion is 2009-12.
What conditions does trial NCT00065806 study?
This clinical trial studies the following conditions: Lupus Erythematosus, Systemic.
What interventions are being tested in trial NCT00065806?
The interventions under investigation include: Atorvastatin (DRUG), Placebo atorvastatin (DRUG).
Who is sponsoring clinical trial NCT00065806?
This trial is sponsored by Laura Schanberg, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00065806 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00065806's enrollment target sits among peer trials
221 9th of 29 higher than 21 of 29 other Lupus Erythematosus, Systemic trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lupus Erythematosus, Systemic trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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