NCT02956590

Dyslipidemia of Obesity Intervention in Teens

Dyslipidemia of Obesity Intervention in Teens Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Carelon Research · Academic / Other
• Sex: All
• Age: 10 Years – 19 Years
• Healthy volunteers: Not accepted

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.

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 triglycerides (TG)/HDL-C ratio or low HDL-C). Enrollment will take place over 36 months.

Conditions

• Dyslipidemia
• Obesity

Interventions

Type	Name	Description
DRUG	Pitavastatin	Statin
DRUG	Placebo	Placebo

Timeline

• Start date: 2018-05-01
• Primary completion: 2023-04-21
• Completion: 2023-06-30
• First posted: 2016-11-07
• Last updated: 2024-07-05

Locations

16 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study