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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am between 8 and 21 years old.
Select...
I have the SLCO1B1 c.521TT genotype.

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

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

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
245 Previous Clinical Trials
935,898 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What does Rosuvastatin 10mg typically target for treatment?

"A common treatment for hypertriglyceridemias is Rosuvastatin 10mg. This form of medication is also employed to address cardiovascular diseases, events, and surgeries."

Answered by AI

What are the eligibility criteria for participants in this trial?

"For this medical trial, 50 individuals aged 8 to 21 with cholesterol are needed. The key requirements for participation include the SLCO1B1 c.521TT genotype, a minimum of eight hours of fasting, and providing informed permission-assent (if under 18) or consent (if over 18)."

Answered by AI

What is the current participant count of this clinical trial?

"Affirmative, according to the data available on clinicaltrials.gov this study is actively seeking out potential participants. This medical trial was inaugurated on April 1st 2021 and last modified July 1st 2022; it requires 50 individuals from a single site."

Answered by AI

Is enrollment still available for this experimental trial?

"Affirmative. Clinicaltrials.gov records demonstrate that this trial, which was first launched on April 1st 2021, is actively recruiting participants. It hopes to accept 50 patients from one medical center."

Answered by AI

Is this clinical research open to geriatric participants?

"This experiment is open to participants aged 8 and above, up until 21 years old."

Answered by AI

Has the FDA sanctioned Rosuvastatin 10mg for medicinal use?

"Rosuvastatin 10mg has only been minimally studied, so it was assigned a safety rating of 1 on the scale from our team at Power."

Answered by AI
~1 spots leftby Apr 2024