N/A N=5 Gene Analysis and Treatment Optimization in Chinese Homozygous Familial Hypercholesterolemia
Homozygous Familial Hypercholesterolemia
Primary: Number of LDLR Gene Mutations — 7 gene mutations
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 2 N=2 Orlistat for the Treatment of Type I Hyperlipoproteinemia
Hyperlipoproteinemia Type I · Hypertriglyceridemia
Primary: Fasting Serum Triglycerides — 705; 1827; 1511; 1007 mg/dL
N/A N=11 Familial Hyperlipidemia Family Registry
Familial Hyperlipidemia
Primary: Familial Hypercholesterolemia (FH) Determination for Family Members of School Children With Elevated Cholesterol and Documented FH Variant — 3; 8 participants
N/A N=57 Effect of Diabetes Mellitus on Cholesterol Metabolism
Type 1 Diabetes Mellitus · Type 2 Diabetes Mellitus · Hypercholesterolemia
Primary: Changes in LDL Cholesterol — -0.83; -1.47; -0.93; -0.32 mmol/L
Phase 3 N=20 Effects of Selective Inhibition of Cholesterol Absorption With Ezetimibe on Intestinal Cholesterol Homeostasis in Dyslipidemic Men With Insulin-resistance - a Pilot Study
Metabolic Syndrome X
Primary: Change in Intestinal mRNA Expression Levels of LDL Receptor Between the Two 12-week Interventions — 110531; 95140 #copies/100000 copies housekeeping gene
Phase 3 N=233 Phase III Study To Evaluate Alirocumab in Patients With Hypercholesterolemia Not Treated With a Statin (ODYSSEY CHOICE II)
Hypercholesterolemia
Primary: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT Analysis) — 4.7; -53.5; -51.7 percent change — p=<0.0001
Phase 3 N=1,220 To Evaluate Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) in Patients With Type IIa or Type IIb Hyperlipidemia (0653A-091)(COMPLETED)
Hypercholesterolemia
Primary: Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) — -20.1; -58.5 Percent change — p=<0.001
Phase 2 N=619 Phase 2 Dose-Ranging Efficacy and Safety Trial of SCH 900271 in Participants With Primary Hypercholesterolemia or Mixed Hyperlipidemia (P05675)
Primary Hypercholesterolemia · Mixed Hyperlipidemia
Primary: Change From Baseline in Direct LDL-C at Week 8 — -2.0; -1.5; -4.2; 0.2 Percent change — p=0.06
Phase 4 N=25 Effects of Statin and Ezetimibe Association on Kinetics of Artificial Chilomicrons
Coronary Heart Disease
Primary: Cholesteryl Ester Fractional Clearance Rate
Phase 3 N=309 A Study of the Safety and Efficacy of Two Different Regimens of Mipomersen in Patients With Familial Hypercholesterolemia and Inadequately Controlled Low-Density Lipoprotein Cholesterol
Hypercholesterolemia · Heterozygous Familial
Primary: Percent Change From Baseline To Primary Endpoint Visit (PET) In LDL-C In Cohort 1 — -27.17; -6.77; -22.96; -10.62 Percent
Phase 3 N=130 A Long-term Trial of ETC-1002 in Patients With Hyper-LDL Cholesterolemia
Hyper-low-density Lipoprotein (LDL) Cholesterolemia
Primary: Number of Subjects Experiencing Treatment-Emergent Adverse Events (TEAEs) — 109 Participants
Phase 3 N=51 Study to Assess the Safety and Efficacy of ISIS 301012 (Mipomersen) in Homozygous Familial Hypercholesterolemia
Lipid Metabolism, Inborn Errors · Hypercholesterolemia, Autosomal Dominant · Hyperlipidemias
Primary: Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Primary Efficacy Time Point — -3.31; -24.66 percentage of baseline — p=<0.001
Phase 2 N=21 Open Label Extension of ISIS 301012 (Mipomersen) to Treat Familial Hypercholesterolemia
Lipid Metabolism, Inborn Errors · Hypercholesterolemia, Autosomal Dominant · Hyperlipidemias
Primary: Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) — -16.2; -2.6; -32.4; 30.6 percentage of baseline
Phase 3 N=370 A 52 Week Study To Assess The Use Of Bococizumab (PF-04950615; RN316) In Subjects With Heterozygous Familial Hypercholesterolemia
Heterozygous Familial Hypercholesterolemia
Primary: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 — -0.3; -54.2 percent change — p=<0.001
Phase 3 N=2,414 MK-0524B Lipid Study (MK-0524B-063)
Primary Hypercholesterolemia · Mixed Dyslipidemia
Primary: Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) — -44.6; -46.9; -48.9; -50.4 Percentage Change
N/A N=111 Study of Cholesterol Levels and Types in African Americans With Type 2 Diabetes
Type 2 Diabetes · African American · Cholesterol
Primary: ApoB Levels in African American Men With Diabetes and Those Without. — 80; 65 mg/dL — p==0.002
Phase 2 N=36 Safety Study of AEM-28 to Treat Refractory Hypercholesterolemia
Hypercholesterolemia · Hyperlipoproteinemia Type II
Primary: Number of Participants Who Incurred at Least One Treatment Emergent Event — 33; 10 participants
Phase 2 N=91 YELLOW II Study: Reduction in Coronary Yellow Plaque, Lipids and Vascular Inflammation by Aggressive Lipid Lowering
Obstructive Coronary Artery Disease · Coronary Artery Disease
Primary: Correlation Between Plaque Morphology and HDL Functionality — 0.30 beta coefficient
Phase 3 N=2,340 Lipid Efficacy and Safety in Participants With Mixed Hyperlipidemia (MK-0524B-024)
Mixed Hyperlipidemia
Primary: Percentage Change From Baseline in the LDL-C/HDL-C Ratio — -50.9; -53.0; -37.6; -42.4 Percentage Change — p=<0.001
Phase 3 N=1,547 MK0653C in High Cardiovascular Risk Patients With High Cholesterol (Switch Study)(MK-0653C-162)
Hypercholesterolemia
Primary: Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Phase I) — -24.8; -10.1; -13.8 Percentage Change — p=<0.001
Phase 2 N=177 A Study to Assess the Efficacy and Safety of ETC-1002 in Subjects With Elevated Blood Cholesterol and Either Normal or Elevated Triglycerides
Dyslipidemia
Primary: Percent Change From Baseline to Week 12 in Calculated Low-Density Lipoprotein-Cholesterol (LDL-C) — -17.9; -25.0; -26.6; -2.1 Percent Change — p=<0.0001
Phase 3 N=124 Efficacy and Safety Study of ISIS 301012 (Mipomersen) as Add-on in Familial Hypercholesterolemic Patients With Coronary Artery Disease
Heterozygous Familial Hypercholesterolemia · Coronary Artery Disease
Primary: Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at the Primary Efficacy Time Point — 5.17; -28.02 percentage of Baseline — p=<0.001
Phase 2 N=266 Study of Evinacumab (REGN1500) in Participants With Persistent Hypercholesterolemia
Hypercholesterolemia
Primary: Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol (LDL-C) at Week 16 (Intent-to-Treat [ITT] Estimand) — 8.8; -29.7; -44.0; -47.2 Percent…
N/A N=57 The Genetic, Protein, and Lipid Basis of Variation in Cholesterol Efflux
Lipid Metabolism Disorders
Primary: Cholesterol Efflux Capacity (CEC) — 1.30; 0.65 Ratio
Phase 4 N=52 Effect On Serum Cholesterol Of Dairy Products With Addition Of Esterified Phytosterols
Dyslipidemias · Hypercholesterolemia
Primary: Serum LDL Cholesterol — 122.2; 113.5 mg/dl
Phase 3 N=142 An Open-label Extension Study to Assess the Long-term Safety and Efficacy of ISIS 301012 (Mipomersen) in Patients With Familial Hypercholesterolemia or Severe-Hypercholesterolemia
Lipid Metabolism, Inborn Errors · Hypercholesterolemia, Autosomal Dominant · Hyperlipidemias
Primary: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) — -28.5; -27; -27.3; -27.9 percent change
Phase 3 N=331 Reduction of LDL-C With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study-2
Hyperlipidemia
Primary: Percent Change From Baseline in LDL-C at Week 12 — -2.02; 5.53; -61.25; -55.74 percent change — p=<0.001
Phase 3 N=67 The APPROACH Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Patients With Familial Chylomicronemia Syndrome
Familial Chylomicronemia Syndrome
Primary: Percent Change in Fasting Triglycerides (TG) From Baseline to Month 3 — 17.6; -76.5 percent change — p=< 0.0001
Phase 2 N=3 Phase 2 Study of AKCEA-ANGPTL3-LRx (ISIS 703802) in Participants With Familial Chylomicronemia Syndrome (FCS)
Familial Chylomicronemia Syndrome · Lipoprotein Lipase Deficiency · Hyperlipoproteinemia Type 1
Primary: Absolute Change From Baseline to Month 3 in Fasting Triglycerides (TG) — -550.00 mg/dL
Phase 3 N=96 A Confirmatory Trial of ETC-1002 in Patients With Hyper-LDL Cholesterolemia
Hyper-low-density Lipoprotein (LDL) Cholesterolemia
Primary: Percent Change in LDL-C From Baseline to Week 12 — -25.25; -3.46 Percent Change — p=0.001