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HMG-CoA Reductase Inhibitor

Statins for High Cholesterol in Children

Phase 1
Recruiting
Research Sponsored by Children's Mercy Hospital Kansas City
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
8-21 years old
SLCO1B1 c.521TT genotype
Must not have
Inability to swallow a tablet
Diarrhea in the last 24 hours
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at how well statins work in children with different levels of liver fat.

Who is the study for?
This trial is for obese and non-obese children and adolescents aged 8-21 with high LDL cholesterol levels who have a specific genotype (SLCO1B1 c.521TT). They must not be on statin therapy, can't be pregnant, should not have significant heart defects or unsafe metal implants for MRI, and must be able to swallow tablets.
What is being tested?
The study tests the effects of Rosuvastatin (10mg) on liver fat in kids with high cholesterol. It's an open-label trial meaning everyone knows what treatment they're getting. The focus is on how body fat influences the drug's transport and effectiveness in the liver.
What are the potential side effects?
Potential side effects of Rosuvastatin may include headache, nausea, muscle pain, abdominal pain, weakness, dizziness. In rare cases it can cause serious muscle problems or liver issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 8 and 21 years old.
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I have the SLCO1B1 c.521TT genotype.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot swallow pills.
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I have had diarrhea in the past day.
Select...
I have heart defects from birth or acquired that haven't been fixed or still cause issues after repair.
Select...
I have a condition that could affect how my body handles the drug rosuvastatin.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Evaluate effect of Liver Fat Percentage (on MRI) on AUC
Evaluate effect of Liver Fat Percentage (on MRI) on change on plasma mevalonate level

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Mevalonate Change After RosuvastatinExperimental Treatment1 Intervention
Group II: Baseline Mevalonate and MRI ImagingActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rosuvastatin 10mg
2014
Completed Phase 3
~850

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Children's Mercy Hospital Kansas CityLead Sponsor
257 Previous Clinical Trials
940,446 Total Patients Enrolled

Media Library

Rosuvastatin (HMG-CoA Reductase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04903223 — Phase 1
High Cholesterol Research Study Groups: Baseline Mevalonate and MRI Imaging, Mevalonate Change After Rosuvastatin
High Cholesterol Clinical Trial 2023: Rosuvastatin Highlights & Side Effects. Trial Name: NCT04903223 — Phase 1
Rosuvastatin (HMG-CoA Reductase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04903223 — Phase 1
~0 spots leftby Jan 2025
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