BridgeMD
New treatment option for Cholesterol; Lipidosis
Official title Liver Adiposity Effects on Pediatric Statin
ClinicalTrials.gov ID: NCT04903223
What this study is testing
What is Rosuvastatin 10mg?
Rosuvastatin 10mg is an investigational medicine, being studied as a potential treatment for cholesterol; lipidosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Single center, open-label, prospective investigation to quantify the effects hepatocellular fat has on hepatic statin transport and response in children and adolescents in obese and non-obese children and adolescents 8-21 years of age with normal, wild-type SLCO1B1 c.521TT genotype that are dosed rosuvastatin
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 to 21. Healthy volunteers may be eligible.
You may be able to join if
- 8-21 years
- LDL cholesterol \>130mg/dl (\>95% percentile)
- SLCO1B1 c.521TT genotype
- Provide informed permission-assent(\<18 yrs.) or consent (≥18 yrs.)
- Fasting overnight (\~8 hrs.)
You likely can't join if
- Pregnancy
- Non-fasting
- Non-removable metal in body or MRI unsafe
- Currently on statin therapy and unwilling to wash out of statin therapy for at least 4 weeks prior to Visit 1 and throughout the duration of the...
- Underlying unrepaired congenital or acquired cardiovascular defects or repaired congenital or acquired cardiovascular defects with hemodynamically...
- History of underlying or laboratory evidence of underlying intestinal, metabolic, autoimmune, renal disease that can alter rosuvastatin disposition\...
See the full eligibility criteria
- 8-21 years
- LDL cholesterol \>130mg/dl (\>95% percentile)
- SLCO1B1 c.521TT genotype
- Provide informed permission-assent(\<18 yrs.) or consent (≥18 yrs.)
- Fasting overnight (\~8 hrs.)
- Enrolled in Cardiology Pharmacogenomic Repository
- Pregnancy
- Non-fasting
- Non-removable metal in body or MRI unsafe
- Currently on statin therapy and unwilling to wash out of statin therapy for at least 4 weeks prior to Visit 1 and throughout the duration of the study.
- Underlying unrepaired congenital or acquired cardiovascular defects or repaired congenital or acquired cardiovascular defects with hemodynamically significant residual disease.
- History of underlying or laboratory evidence of underlying intestinal, metabolic, autoimmune, renal disease that can alter rosuvastatin disposition\ (absorption, metabolism, distribution, or clearance)
- Pharmacotherapy that interacts with statins (OATP1B1 inducers/inhibitors) \
- Inability to swallow a tablet
- \>5x the age-specific upper limit of normal for AST, ALT, total and conjugated bilirubin
- Diarrhea in the last 24 hours
- Anything that would exclude a participant from completing an MRI, such as pacemakers, claustrophobia, or body habitus (e.g., weight greater than 350 lbs.)
The study team makes the final eligibility decision.
Where it's taking place
- Kansas City, Missouri, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 8 years to 21 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kansas City, Missouri, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.