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Atherosclerosis Prevention in Pediatric Lupus Erythematosus (APPLE) Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Atherosclerosis Prevention in Pediatric Lupus Erythematosus (APPLE) conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Atherosclerosis Prevention in Pediatric Lupus Erythematosus (APPLE) Clinical research trials and Atherosclerosis Prevention in Pediatric Lupus Erythematosus (APPLE) health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Atherosclerosis Prevention in Pediatric Lupus Erythematosus (APPLE). Atherosclerosis Prevention in Pediatric Lupus Erythematosus (APPLE) Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Atherosclerosis Prevention in Pediatric Lupus Erythematosus (APPLE) clinical trial. Participants oftentimes recieve the most expert healthcare available for their Atherosclerosis Prevention in Pediatric Lupus Erythematosus (APPLE) condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > Atherosclerosis Prevention in Pediatric Lupus Erythematosus (APPLE)  Atherosclerosis Prevention in Pediatric Lupus Erythematosus (APPLE)
Atherosclerosis Prevention in Pediatric Lupus Erythematosus (APPLE)
For Condition: Lupus Erythematosus, Systemic
Status: Recruiting
Sponsor(s): National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) ,
Synopsis: High cholesterol levels are common in people with Systemic Lupus Erythematosus (SLE). Atorvastatin is a drug that reduces cholesterol levels. This study will test whether atorvastatin can reduce cholesterol levels in children with SLE.
Details: Children and adolescents with SLE represent 15% of all SLE patients. Children with SLE suffer high morbidity that affects many organ systems, reduces their quality of life, and shortens their lifespan. As more children with SLE survive into adulthood, atherosclerotic cardiovascular disease has emerged as a major concern. SLE is a significant risk factor for myocardial infarction and death in young premenopausal women with SLE, even after controlling for traditional cardiovascular risk factors. Acceleration of atherogenesis in SLE most likely reflects SLE-associated vascular immune and inflammatory changes. Although limited, the data on cardiovascular and lipid abnormalities in children with SLE implicate atherosclerosis as an important cause of long-term morbidity and mortality. The 3-hydroxy-3-methlglutaryl-coenzyme A (HMG CoA) reductase inhibitors, or statins, reduce mortality and morbidity from atherosclerosis in adults and have intrinsic anti-inflammatory and immune modulatory properties. These anti-inflammatory and immune modulatory activities may have particular benefit in the prevention and treatment of atherosclerosis in SLE. This trial will evaluate atorvastatin in children with SLE in the largest cohort of pediatric SLE patients ever studied prospectively. Children in this study will be randomized to receive either atorvastatin or a placebo. All children will be followed for 3 years, during which they will have 15 study visits. Study visits will generally last 2 hours and will include medical interview, medication review and pill count, physical examination, and blood and urine tests. Cardiovascular-specific outcome measures will include assessments of high sensitivity CRP; fasting lipid profile; homocysteine level; apolipoprotein A, B1, and Lp(a); carotid intima media thickness (IMT); and tensor diffusion/MRI.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study
Minimum Age/Maximum Age: 10 Years/18 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - Meets American College of Rheumatology (ACR) revised diagnostic guidelines for SLE - Weight >= 25 kg (55 lbs) - Outpatient - Ability to complete self-report questionnaires in either English or Spanish - Willingness to comply with recommended diet - Acceptable methods of contraception Exclusion Criteria - Drug-induced lupus - Liver disease (ALT or aspartate aminotransferase > 2 X normal value) - Myositis (CK > 3 X normal value) - Inability to obtain adequate-quality IMT images - Current use of oral or parenteral tacrolimus or cyclosporine - Dialysis or serum creatinine > 2.5 mg/dL - Active nephrotic syndrome (urinary protein > 3 g/24 h and serum albumin < 2.3 g/dl) - Total cholesterol > 350 mg/dL - Xanthoma - Familial hypercholesterolemia - Pregnant or breastfeeding - Use of estrogen-containing contraceptives (e.g., Lo-Ovral) - Unable to adhere to study regimen - Life-threatening non-SLE illness that would interfere with ability to complete the study - Current drug or alcohol abuse - Anticipated poor compliance - Participation in another drug intervention study within 30 days of study enrollment
Total Enrollment: 280
Location and Contact Information:
Overall Study Official:
LauraSchanberg, Principal Investigator, Duke Medical Center
Duke Medical Center / Duke Clinical Research Institute *Recruiting*
Durham, North Carolina, 27715
United States
Recruiting Richard Brown 919-668-8104
Additional Information:
Study ID Numbers: NIAMS-090; 1 NO1 AR22256-01
Study Start Date: September 2003
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00065806
Other Lupus Erythematosus, Systemic Studies:
1. Lupus Cohort--Thrombotic Events and Coronary Artery Disease
2. Study of LymphoStat-B in Subjects with Systemic Lupus Erythematosus (SLE)
3. Atherosclerosis Prevention in Pediatric Lupus Erythematosus (APPLE)
4. Anti-CD20 in Systemic Lupus Erythematosus
5. Phase II Pilot Study of Cytarabine for Refractory Systemic Lupus Erythematosus
Related Studies:
Other Lupus Erythematosus, Systemic Clinical Trials
Other North Carolina Clinical Trials
Other Durham Clinical Trials
Atherosclerosis Prevention in Pediatric Lupus Erythematosus (APPLE)
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