Atherosclerosis Prevention in Pediatric Lupus Erythematosus (APPLE)

PHASE3CompletedINTERVENTIONAL
Enrollment

221

Participants

Timeline

Start Date

September 30, 2003

Primary Completion Date

December 31, 2009

Study Completion Date

December 31, 2009

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.

Trial Locations (1)

27715

Duke Medical Center / Duke Clinical Research Institute, Durham

All Listed Sponsors
lead

Laura Schanberg

OTHER

NCT00065806 - Atherosclerosis Prevention in Pediatric Lupus Erythematosus (APPLE) | Biotech Hunter | Biotech Hunter