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=9 Study of REGN1500 in Participants With Homozygous Familial Hypercholesterolemia (HoFH)
Homozygous Familial Hypercholesterolemia
Primary: Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) to Week 4 in the Main Study Period — -49.17 Percent Change
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…
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 1 N=49 A Pharmacokinetic and Pharmacodynamic Study of PF-04950615 (RN316) in Subjects With Hypercholesterolemia
Hypercholesterolemia · Dyslipidemias · Hyperlipidemias
Primary: Maximum Observed Plasma Concentration (Cmax) of PF-04950615 — 65810; 15900; 8922; 10470 nanogram per milliliter (ng/mL)
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
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 2 N=168 Reduction of Low-Density Lipoprotein Cholesterol (LDL-C) With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study
Hypercholesterolemia, Familial
Primary: Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 — 1.12; -42.70; -55.24 percent change — p=<0.001
Phase 2 N=116 Study of MGL-3196 in Patients With Heterozygous Familial Hypercholesterolemia (HeFH)
Heterozygous Familial Hypercholesterolemia
Primary: Mean Percent Change in LDL-C From Baseline To Week 12 — -10.6; 8.2 percent change — p=<0.0001
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=58 Trial Evaluating PCSK9 Antibody in Subjects With LDL Receptor Abnormalities
Homozygous Familial Hypercholesterolemia
Primary: Part A: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 — -16.5 percent change
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=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 3 N=300 Trial Assessing Long Term USe of PCSK9 Inhibition in Subjects With Genetic LDL Disorders
Severe Familial Hypercholesterolemia
Primary: Number of Participants With Adverse Events — 94; 174; 76; 143 Participants
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
Phase 4 N=32 Effects of Prescription Omega-3 on LDL-C in Primary Hypercholesterolemia
Primary Hypercholesterolemia
Primary: Percent Change From Baseline in LDL-C During Each Treatment — 3.4; -0.7 Percent change from baseline
Phase 3 N=58 A Study to Evaluate the Effects of Ezetimibe (MK-0653) on the Postprandial (Following a Meal) Lipoprotein Response in Participants With Primary Hypercholesterolemia (High Cholesterol) (MK-0653-072)(COMPLETED)
Hypercholesterolemia
Primary: Total Cholesterol Concentration of Chylomicron (Sf≥400) Fractions After a Cholesterol-Rich Test Meal — 0.45; 0.50 mg/dL — p=0.241
Phase 3 N=303 A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017/CORALreef HeFH)
Hypercholesterolemia · Familial Hypercholesterolemia
Primary: Mean Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24 — -58.2; 2.6 Percent Change — p=<0.001
Phase 3 N=146 Coadministration of Ezetimibe and Atorvastatin in Patients With Primary Hypercholesterolemia (P05456)
Hypercholesterolemia
Primary: Number of Participants With Adverse Events and Adverse Reactions — 141; 61 Participants
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 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
Phase 4 N=194 Efficacy and Safety of Colesevelam in Pediatric Patients With Genetic High Cholesterol
Hypercholesterolemia
Primary: Percent Change in Plasma Low Density Lipoprotein-cholesterol (LDL-C) From Day 1 (Study Baseline) to Week 8. — 2.9; -3.7; -10.6 percent change from baseline — p=0.1122
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 3 N=151 Coadministration of Ezetimibe and Simvastatin in Patients With Primary Hypercholesterolemia (P05457)
Hypercholesterolemia
Primary: Number of Participants With Adverse Events and Adverse Reactions — 143; 36 Participants
Phase 3 N=65 Efficacy and Safety of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia
Homozygous Familial Hypercholesterolemia
Primary: Percent Change in Calculated Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 24 (Intent-to-Treat [ITT] Estimand) — 1.9; -47.1 Percent Change — p=< 0.0001
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=138 Pediatric Study to Evaluate the Efficacy and Safety of Ezetimibe Monotherapy in Children With Primary Hypercholesterolemia (P05522)
Primary Hypercholesterolemia
Primary: Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12 — -27.70; -0.95 Percent Change — p=<0.001
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 2 N=77 Study of the Safety and Efficacy of REGN727/SAR236553 in Patients With HeFH Hypercholesterolemia
Hypercholesterolemia
Primary: Percent Change From Baseline in Calculated LDL-C at Week 12 - On-treatment Analysis — -10.7; -28.9; -31.5; -42.5 percent change — p=0.0000
N/A N=8 Acute Microvascular Changes With LDL Apheresis
Hyperlipidemia
Primary: Myocardial Perfusion at Rest — 55; 135 IU/s