We are doing this research study to find out if a drug that lowers cholesterol, called pitavastatin, can help lower cholesterol in children and teens who are obese with high cholesterol.
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This condition of obesity with high cholesterol is sometimes called “Combined Dyslipidemia of Obesity” or CDO. When people have CDO for many years, it can cause their arteries to harden and narrow (called atherosclerosis). This can then lead to serious health problems including heart attack, stroke, or even death.
Pitavastatin is commonly known as Livalo and belongs to a group of cholesterol lowering medicines called statins. It is approved by the Food and Drug Administration (FDA) and Health Canada for use in adults and in children with another type of high cholesterol. It lowers blood total cholesterol as well as “bad” cholesterol (called LDL) that raises the risk of heart disease and heart attacks. It also increases the “good” type of cholesterol (called HDL).
For more information, visit ClinicalTrials.gov.
Male or females between the age of 10 and 17 who have Combined Dyslipidemia of Obesity (CDO).
The study will be explained to you in detail by one of the study investigators. Once your questions have been answered, you will be asked to sign an informed consent form/assent form to enter the study. This is what needs to be done in the study:
If you/your child qualifies for this study, it will take 24 months for him/her to complete participation in this research study.
You or your child may not benefit from taking part in this research study. But the information we learn from this study may help improve the care of other children.
There will be no extra costs to you when you join this study. You must pay for all other costs related to your normal medical care such as hospital stays, surgery, drugs, lab tests, and doctor’s fees which are thought to be standard medical care for patients with your condition.