Purpose

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

Eligibility

Eligible Ages
Between 10 Years and 17 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Boys and girls aged 10 to 17 years (with 2 year availability for study participation)
  • BMI >95th percentile (using CDC BMI charts)
  • Fasting lipid profile x2 each with all of the following:
  • LDL-C <160 mg/dL, and
  • TG <500 mg/dL, and
  • TG/HDL-C ratio > 3.0 or HDL-C <45 mg/dL for boys or HDL-C <50 mg/dL for girls, and
  • non-HDL-C >145 mg/dL
  • Participant consent, or parental/guardian consent and participant assent
  • Participant fluency in English

Exclusion Criteria

  • Current use of lipid lowering medication, antihypertensive medication, growth hormone, systemic corticosteroids, cyclosporine, protease inhibitors, colchicine, warfarin, second generation psychotropic drugs, oral isotretinoin; stable doses of stimulant or antidepressant therapy will be accepted
  • Female who is pregnant, plans to become pregnant or is sexually active without contraception
  • Stage 2 hypertension (systolic or diastolic blood pressure above the 99th percentile for age, sex and height percentile + 5 mmHg; confirmed after an appropriate evaluation)
  • Diabetes (type 1 or type 2) by American Diabetes Association criteria (fasting glucose >126 mg/dL, random glucose >200 mg/dL, or 2-hour oral glucose tolerance testing glucose >200 mg/dL)
  • Prediabetes or polycystic ovary syndrome on insulin sensitizing therapy
  • Known renal insufficiency
  • Uncontrolled thyroid disease
  • Proteinuria suggestive of renal disease (urine protein: creatinine >0.2)
  • 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) ≥ 50 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Pitavastatin
Study Drug
  • Drug: Pitavastatin
    Statin
    Other names:
    • Livalo
Placebo Comparator
Placebo
Placebo
  • Drug: Placebo
    Placebo

Recruiting Locations

Children's National and nearby locations

Children's National Health System
Washington, District of Columbia 20010
Contact:
Michele Mietus-Snyder, MD
mmsynder@childrensnational.org

More Details

NCT ID
NCT02956590
Status
Recruiting
Sponsor
HealthCore-NERI

Study Contact

Julie Miller, MPH
617-972-3197
jmiller@healthcore.com

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 obese (body mass index >95th percentile) adolescents with CDO (defined as high non-HDL-C + high TG/HDL-C ratio or low HDL-C). Enrollment will take place over 18 months.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.