Pilot Program to Improve Statin Adherence and Lower Cholesterol in Older Adults
HypercholesterolemiaMedication AdherenceThe purpose of this study is to pilot test a behavioral medication adherence (MA) intervention compared to control condition in older adults with low adherence to medication for hypercholesterolemia.
Pharmacokinetic And Pharmacodynamic Study Of A Single-Dose Of PF-04950615 (RN316) In Combination...
HypercholesterolemiaDyslipidemiaThe primary objective of this study is to evaluate the pharmacokinetics and pharmacodynamics of a single dose of PF-04950615 (RN316) in volunteers on stable doses of atorvastatin. PF-04950615 (RN316) is an investigational drug that is currently being studies as a cholesterol lowering therapy.
Statins in Children With Type 1 Diabetes and Hypercholesterolemia
Diabetes MellitusInsulin-Dependent1 moreChildren with type1 diabetes (T1DM) have increased risk for cardiovascular disease (CVD) due to chronic increase in the blood sugars and inflammation. If there is also increased in cholesterol, it creates a highly abnormal environment not fully corrected by improved control of the blood sugars. CVD remains the principal risk of mortality in T1DM, and its prevention and treatment, compelling in children. This grant proposal encompasses 3 separate, yet interrelated projects addressing different aspects of CVD risk in children with T1DM. Project #1: a randomized controlled trial on the safety and efficacy of a class of drugs called "statins", which lower bad cholesterol in the body, in children with diabetes and elevated bad cholesterol. We will measure changes in concentration of blood inflammatory markers and for the 1st time, correlate levels of these markers with changes in blood sugar as measured by continuous glucose sensors, instruments that measure the blood sugar continuously through a small needle under the skin. Project #2: is a laboratory study to investigate the genetics and concentration of key molecules that participate in the inflammatory cascade and atheromatous plaque formation that causes CVD. Expression levels in children with T1DM will be compared with those in healthy controls for the 1st time. Project #3: examines the use of abdominal aortic MRI to measure damage to the arteries in children with T1DM and healthy age-matched controls. The results of these studies will likely provide important new data on the use of statins in children with diabetes.
A Study of the Efficacy and Safety of ETC-1002 in Participants With Statin Intolerance
HypercholesterolemiaThis study will assess the Low-Density Lipoprotein-Cholesterol (LDL-C) lowering efficacy and safety of ETC-1002 versus placebo in participants with hypercholesterolemia and a history of statin intolerance.
Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) in Patients With Primary Hypercholesterolemia...
HypercholesterolemiaAlirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds proprotein convertase subtilisin/kexin type 9 (PCSK9). Primary Objective of the study: To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 12 weeks of treatment in comparison with placebo in participants with LDL-C ≥100 mg/dL (≥2.59 mmol/L) on ongoing stable atorvastatin therapy. Secondary Objectives: To evaluate the effects of alirocumab on other lipid levels after 12 weeks of treatment in comparison with placebo To evaluate the safety and tolerability of alirocumab To evaluate the development of anti-alirocumab antibodies To evaluate the pharmacokinetics of alirocumab
Effect of Omega-3 Fatty Acid on Endothelial Function
Familial HypercholesterolemiaBackground Familial hypercholesterolemia (FH) is an inherited disease in which the level of bad cholesterol (LDL-cholesterol) is increased, leading to an increase in coronary heart disease even if adequately treated with cholesterol lowering medication (statins). Polyunsaturated fatty acids (PUFA) including omega-3 is known to affect the risk for coronary disease, however its effect on patients with FH is not known. The purpose of the study is to assess the effect of PUFA on patients with FH, with regard to inflammation measured in the blood and the effect on the blood vessels'ability to relax (endothelial function) by means of tonometry. Hypothesis Treatment with 4 grams of PUFA a day for 4 months will lead to an improvement in the endothelial function, and the treatment will also lead to a decrease in in several markers of inflammation and in lipids in the blood.
Evaluation of ETC-1002, Ezetimibe, and the Combination in Hypercholesterolemic Patients
HypercholesterolemiaThe purpose of this research study is to see how ETC-1002 is tolerated in the body, to measure the amount of ETC-1002 in the blood, and to determine how ETC-1002 affects the level of LDL-cholesterol (bad cholesterol) and other markers of health and disease in blood and urine in patients with elevated LDL-cholesterol with or without statin intolerance.
Reduction of LDL-C With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder...
HyperlipidemiaThe primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneously once every 2 weeks (Q2W) and once monthly (QM), compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in adults with heterozygous familial hypercholesterolemia (HeFH).
Evaluation of ETC-1002 vs Placebo in Patients Receiving Ongoing Statin Therapy
HypercholesterolemiaThe purpose of this research study is to see how ETC-1002 is tolerated in the body and how ETC-1002 affects the levels of LDL-C (bad cholesterol) in patients receiving ongoing statin therapy.
Safety, Tolerability, PK and PD of LGT209 in Healthy Volunteers and Patients With Hypercholesterolemia...
HypercholesterolemiaThis study is designed to measure the effects of LGT209 when given intravenously to patients with high cholesterol who are on stable doses of statin medications, and to healthy subjects with elevated cholesterol