Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
354

Summary

Conditions
  • Dyslipidemia
  • Obesity
Type
Interventional
Phase
Phase 3
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 10 years and 19 years
Gender
Both males and females

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 tak...

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.

Tracking Information

NCT #
NCT02956590
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Not Provided