Hyperlipidemia Clinical Trial
Official title:
A Placebo-controlled, Participant, Investigator and Sponsor Blinded, Randomized Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Inclisiran Treatment Given as Single Subcutaneous Injection in Chinese Participants With Elevated Low-density Lipoprotein Cholesterol (LDL-C) Despite Treatment With LDL-C Lowering Therapies (ORION-14)
Study to evaluate the pharmacokinetics and pharmacodynamics of inclisiran treatment given as single subcutaneous injection in Chinese participants with elevated low-density lipoprotein cholesterol (LDL-C) despite treatment with LDL-C lowering therapies
The purpose of the study is to characterize pharmacokinetics, pharmacodynamics, safety and tolerability of inclisiran in Chinese participants with elevated serum LDL-C to support inclisiran registration in China.Inclisiran is a long acting RNA therapeutic agent that inhibits the synthesis of PCSK9, leading to reduced circulating LDL-C levels. Three pivotal Phase III studies have been conducted primarily in non-Asian participants to support New Drug Application/Marketing Authorization Application approval of inclisiran globally. This study design is based on the hypothesis that the global inclisiran clinical data primarily obtained in Caucasian participants could be appropriately extrapolated to Chinese participants. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00001154 -
Lipoprotein Metabolism in Normal Volunteers and Patients With High Levels of Lipoproteins
|
||
| Completed |
NCT02927184 -
Safety and Tolerability of VK2809 in Patients With Primary Hypercholesterolemia and Non-Alcoholic Fatty Liver Disease
|
Phase 2 | |
| Completed |
NCT04640012 -
Ascending-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics of DC371739 Single-Dose Treatment in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT03213288 -
Bilberry Fruit and Black Rice Derived Anthocyanins on Lipid Status
|
N/A | |
| Completed |
NCT00382564 -
Magnetic Resonance Angiography to Diagnose Atherosclerotic Disease
|
N/A | |
| Recruiting |
NCT02979704 -
A Comparative Study of Rosuvastatin and Atorvastatin in Patients With Hyperlipidemia
|
Phase 2/Phase 3 | |
| Completed |
NCT02569814 -
A Study to Compare the Pharmacokinetics and Safety of a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin
|
Phase 1 | |
| Completed |
NCT02280590 -
Comparison of the Efficacy and Safety of Cresnon® and Crestor® in Patients With Hyperlipidemia
|
Phase 4 | |
| Completed |
NCT02428998 -
Safety for 24 Weeks Intake of Korean Red Ginseng in Adults
|
N/A | |
| Completed |
NCT01678183 -
Financial Incentives for Medication Adherence
|
N/A | |
| Completed |
NCT01426412 -
A Study of LY3015014 in Healthy Participants With Elevated Low Density Lipoprotein Cholesterol
|
Phase 1 | |
| Completed |
NCT01694446 -
Regulation of Intestinal and Hepatic Lipoprotein Production by Glucose and Fructose
|
N/A | |
| Completed |
NCT01131832 -
Genetic Basis for Heterogeneity in Response of Plasma Lipids to Plant Sterols
|
Phase 4 | |
| Completed |
NCT00534105 -
Lipid Metabolism in Gestational Diabetes
|
N/A | |
| Completed |
NCT00758303 -
A Study to Evaluate the Lipid Regulating Effects of TRIA-662
|
Phase 2/Phase 3 | |
| Recruiting |
NCT00408824 -
Investigation of Genetic Risk of Metabolic Syndrome in Company Employee (NGK Study)
|
N/A | |
| Terminated |
NCT00299169 -
Randomized Trial Comparing N of 1 Trials to Standard Practice to Improve Adherence to Statins in Patients With Diabetes
|
Phase 4 | |
| Completed |
NCT00362206 -
Comparison of the Combination of Fenofibrate and Simvastatin Versus Pravastatin
|
Phase 3 | |
| Completed |
NCT00414986 -
Using Learning Teams for Reflective Adaptation for Diabetes and Depression
|
N/A | |
| Completed |
NCT00381992 -
Risk Assessment of Long-Haul Truck Drivers
|
N/A |