Current Environment:

Summary

This trial of pitavastatin will determine efficacy and safety in this high risk population and provide evidence for clinicians to target this treatable risk factor to achieve an impact on early atherosclerosis, and potentially achieve primary prevention of adult cardiovascular disease.

Conditions

Dyslipidemia, Obesity

Recruitment Status

Active, not recruiting

Detailed Description

Randomized, double-blind, placebo-controlled clinical trial of pitavastatin for 2 years comparing the effect of study drug versus placebo on vascular measures in at least 354 adolescents with excess adiposity and CDO (defined as high non-HDL-C + high TG/HDL-C ratio or low HDL-C). Enrollment will take place over 36 months.

Eligibility Criteria

Inclusion Criteria:

Boys and girls aged 10 to 19 years (with 2-year availability for study participation)
BMI ≥85th percentile (using CDC BMI charts)

Fasting lipid profile x2 each with all of the following:

LDL-C <160 mg/dL and ≥90 mg/dL, and
TG <500 mg/dL, and
TG/HDL-C ratio ≥2.5 or HDL-C <45 mg/dL for boys or HDL-C <50 mg/dL for girls, and
non-HDL-C ≥120 mg/dL
Participant consent, or parental/guardian consent and participant assent

Exclusion Criteria:

Current use of lipid lowering medication, growth hormone, systemic corticosteroids, cyclosporine, protease inhibitors, erythromycin, rifampin, colchicine, warfarin, second generation psychotropic drugs, oral isotretinoin; stable doses of stimulant or antidepressant therapy and antihypertensive medications will be accepted
Known allergy or hypersensitivity to statin
Patients who have had bariatric surgery or plan to have bariatric surgery during the trial
Female who is pregnant, plans to become pregnant or is sexually active without contraception
Uncontrolled stage 2 hypertension (systolic or diastolic blood pressure ≥95th percentile for age, sex and height percentile + 12 mmHg or ≥140/90, whichever is lower for participants <13 years of age; ≥140/90 for participants ≥13 years of age) confirmed after an appropriate evaluation
Diabetes (type 1 or type 2) by American Diabetes Association criteria (fasting glucose ≥126 mg/dL, HbA1c ≥6.5%, random glucose ≥200 mg/dL, or 2-hour oral glucose tolerance testing glucose ≥200 mg/dL)
Use of insulin sensitizing therapy
Known renal insufficiency (known chronic renal disease, estimated GFR <60 mL/min/1.73m2 at screening)
Uncontrolled thyroid disease (TSH at screening >1.5x upper limit of normal, clinical or other laboratory evidence of hypothyroidism, or thyroid hormone therapy that has not been stable for 6 weeks prior to screening)
Proteinuria suggestive of renal disease (more than trace together with an elevated urine protein:creatinine ratio as per local lab)
Syndromic patients or patients with neurocognitive delay precluding adherence with study drug
Liver disease other than non-alcoholic fatty liver disease (NAFLD) either diagnosed or suggested by alanine aminotransferase (ALT) ≥ 40 U/L, or severe NAFLD indicated by ALT ≥ 200 U/L
Unexplained persistent elevated creatine kinase (CK) level >3x upper limit of normal
Plans to leave the geographic area before completion of the anticipated 2 years of trial participation
Any unstable medical or emotional condition or chronic disease that would preclude following the protocol or impact valid vascular measurement
Admits to current smoking, current alcohol consumption

Intervention

Intervention Type

Intervention Name

Drug

Pitavastatin

Drug

Placebo

Phase

Phase 3

Gender

All

Min Age

10 Years

Max Age

19 Years

Download Date

April 22, 2021

Principal Investigator

N/A

Primary Contact Information

For more information on this trial, visit clinicaltrials.gov.

Contact

For more information and to contact the study team: