At a glance
ClinicalIndex Comparison Record- ✓Adolescent aged 10–17 years, weighing ≥88 lbs (40 kg)
- ✓LDL-C >159 mg/dL (>4.1 mmol/L)
- ✓Family history of high cholesterol
- ✕Delayed puberty
- ✕Known sensitivity/hypersensitivity to simvastatin and/or ezetimibe
- ✕Excessive alcohol consumption or history of alcohol or drug abuse within past 2 years
- ✕HIV-positive status
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy, Safety, and Tolerability of Ezetimibe in Coadministration With Simvastatin in the Therapy of Adolescents With Heterozygous Familial Hypercholesterolemia
In Brief
A Phase 3 clinical trial evaluating ezetimibe with simvastatin and simvastatin for Hypercholesterolemia. Completed, enrolled 248 participants.
Detailed Summary
This is a randomized, double-blind, controlled, parallel-group, multicenter, Phase-3 study to evaluate the efficacy and safety of ezetimibe with simvastatin taken alone in subjects ages 10-17 years with Heterozygous Familial Hypercholesterolemia.
Study Details
Timeline
Interventions
Ezetimibe 10 mg plus simvastatin 10 mg once a day for six weeks, or Ezetimibe 10 mg plus simvastatin 20 mg once a day for six weeks, or Ezetimibe 10 mg plus simvastatin 40 mg once a day for six weeks
Ezetimibe matching placebo plus simvastatin 10 mg once a day for six weeks, or Ezetimibe matching placebo plus simvastatin 20 mg once a day for six weeks, or Ezetimibe matching placebo plus simvastatin 40 mg once a day for six weeks