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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 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.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00065806
The ClinicalTrials.gov registry entry for NCT00065806 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 221 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 196-participant average among 29 other Lupus Erythematosus, Systemic trials with a reported enrollment target (13% higher). The listed sponsor is Laura Schanberg, which has 1 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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