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Atherosclerosis Prevention in Pediatric Lupus Erythematosus (APPLE)

NCT00065806 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 221

Last updated 2013-08-15

Study results available
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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

  • Lupus Erythematosus, Systemic

Interventions

DRUG

Atorvastatin

Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months.

DRUG

Placebo atorvastatin

Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months.

Sponsors & Collaborators

  • Laura Schanberg

    lead OTHER

Principal Investigators

  • Laura E. Schanberg, MD · Duke Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-09-30
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00065806 on ClinicalTrials.gov