Effect of Rosuvastatin on Triglyceride Levels in Mexican Hypertriglyceridemic Patients
HypertriglyceridemiaHyperlipoproteinemia Type IV3 moreThe primary purpose of this trial is to determine if the treatment with rosuvastatin 10 and 20mg/day during 8 weeks in hypertriglyceridemic patients will reduce their triglyceride levels.
PLUTO: Pediatric Lipid-redUction Trial of rOsuvastatin
Familial HypercholesterolemiaThe primary objective of this study is to determine the efficacy of once-daily rosuvastatin in reducing LDL-C in children and adolescents aged 10-17 years with HeFH from baseline (Day 0) to the end of the 12-week double-blind treatment period.
Study of ISIS 301012 (Mipomersen) in Heterozygous Familial Hypercholesterolemia Subjects on Lipid...
HypercholesterolemiaFamilialThe aim of this study is to assess the safety and efficacy of varying doses of ISIS 301012 (mipomersen) as add-on therapy in subjects with Heterozygous Familial Hypercholesterolemia
Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia...
Homozygous Familial HypercholesterolemiaThe primary objectives of the study are: To evaluate the long-term safety and tolerability of evinacumab in patients with Homozygous Familial Hypercholesterolemia (HoFH) To evaluate the long-term safety and tolerability of evinacumab in adolescent patients with HoFH The secondary objectives of the study are: To evaluate the effect of evinacumab on lipid parameters in patients with HoFH To evaluate the effect of evinacumab on lipid parameters in adolescent patients with HoFH To evaluate the potential development of anti-evinacumab antibodies
Study of Efficacy and Safety of Inclisiran in Japanese Participants With High Cardiovascular Risk...
HypercholesterolemiaHeterozygous Familial HypercholesterolemiaThis was a placebo-controlled, double-blind, randomized trial in Japanese participants with history of coronary artery disease (CAD) or participants categorized in 'high risk' by JAS 2017 guideline, or Japanese participants with heterozygous familial hypercholesterolemia (HeFH) and elevated Low-density lipoprotein cholesterol (LDL-C) despite maximum tolerated dose of statin(s) to evaluate the efficacy, safety, tolerability, and PK of subcutaneous inclisiran injection(s).
Study in Participants With Homozygous Familial Hypercholesterolemia (HoFH)
Homozygous Familial HypercholesterolemiaThe primary objective of the study is to demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) with alirocumab subcutaneous (SC) every 2 weeks (Q2W) in comparison to placebo after 12 weeks of treatment. The secondary objectives of the study are: To evaluate the effect of alirocumab Q2W on other lipid parameters (ie, apolipoprotein [Apo] A-1 and B, non-high-density lipoprotein cholesterol [non-HDL-C], total-cholesterol [TC], proportion of participants with 15%, 30%, and 50% LDL-C reductions, Lp(a), HDL-C, triglycerides [TG]) in participants with HoFH To evaluate the safety and tolerability of alirocumab SC Q2W in participants with HoFH To assess the pharmacokinetics of alirocumab SC Q2W in participants with HoFH To assess the potential development of anti-drug (alirocumab) antibodies
Efficacy and Safety Study of ISIS 301012 (Mipomersen) as Add-on in Familial Hypercholesterolemic...
Heterozygous Familial HypercholesterolemiaCoronary Artery DiseaseThe purpose of this study is to determine whether mipomersen safely and effectively lowers low-density lipoprotein cholesterol (LDL-C) in patients with Heterozygous Familial Hypercholesterolemia (HeFH) and coronary artery disease (CAD) who are already on a stable dose of other lipid-lowering agents (including maximally tolerated statin therapy).
An Open-label Extension Study to Assess the Long-term Safety and Efficacy of ISIS 301012 (Mipomersen)...
Lipid MetabolismInborn Errors18 moreTo evaluate the safety and efficacy of extended dosing with mipomersen (ISIS 301012) in participants with familial hypercholesterolemia or severe hypercholesterolemia on lipid-lowering therapy who had completed either the 301012-CS5 (NCT00607373), 301012-CS7 (NCT00706849), 301012-CS17 (NCT00477594) or MIPO3500108 (NCT00794664) clinical drug trials.
Low-Density Lipoprotein (LDL) Apheresis Using H.E.L.P. Therapy
Familial HypercholesterolemiaThe objectives of this post-surveillance study are to continue to evaluate the safety and effectiveness of the H.E.L.P. System. The safety and effectiveness will be assessed by evaluating the occurrence of death, cardiovascular events or interventions, angina, and serious unanticipated adverse effects. Laboratory assessments will be made to document low-density lipoprotein cholesterol (LDL-C) reduction and any effects on other blood components. Quality of life assessments will also be made. The study will also assess the modifications to the H.E.L.P. System, including: use of a single heparin adsorber, instead of two smaller adsorbers; change in the supplier of the ultrafilter (from Secon to Toray); reduction in the number of blood lines from eleven to nine; change from a single-layer to a two-layer precipitate filter. The safety and efficacy of the device specific to these modifications will be evaluated by comparing the safety and efficacy data from the patient registry to the data from the initial clinical study on the device as originally designed.
Open Label Extension of ISIS 301012 (Mipomersen) to Treat Familial Hypercholesterolemia
Lipid MetabolismInborn Errors18 moreThe purpose of this study is to evaluate the safety and efficacy of extended dosing of mipomersen in patients with familial hypercholesterolemia on lipid-lowering therapy who have completed either the 301012-CS8 (NCT00280995) or 301012-CS9 (NCT00281008) clinical drug trials.