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Study of Efficacy and Safety of Inclisiran in Asian Participants With Atherosclerotic Cardiovascular Disease (ASCVD) or ASCVD High Risk and Elevated Low Density Lipoprotein Cholesterol (LDL-C)
Sponsor: Novartis Pharmaceuticals
Summary
A multicenter study to evaluate safety and efficacy of inclisiran in Asian patients with ASCVD or ASCVD high risk and elevated LDL-C
Official title: A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Inclisiran in Asian Patients With ASCVD or ASCVD High Risk and Elevated Low-density Lipoprotein Cholesterol as an Adjunct to Diet and Maximally Tolerated Statins With or Without Additional Lipid-lowering Therapy (ORION-18)
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
345
Start Date
2021-03-01
Completion Date
2026-12-28
Last Updated
2025-12-30
Healthy Volunteers
No
Conditions
Interventions
inclisiran sodium
Subcutaneously injected on Day 1, 90 and 270 (Core Part). Subcutaneously injected on Day 360 and every 6 months thereafter until EOS visit (Extension Part)
Placebo
Subcutaneously injected on Day 1, 90, and 270.
Locations (45)
Novartis Investigative Site
Lanzhou, Gansu, China
Novartis Investigative Site
Foshan, Guangdong, China
Novartis Investigative Site
Guangzhou, Guangdong, China
Novartis Investigative Site
Shijiazhuang, Hebei, China
Novartis Investigative Site
Baotou, Inner Mongolia, China
Novartis Investigative Site
Hohhot, Inner Mongolia, China
Novartis Investigative Site
Nanjing, Jiangsu, China
Novartis Investigative Site
Nanjing, Jiangsu, China
Novartis Investigative Site
Nantong, Jiangsu, China
Novartis Investigative Site
Suzhou, Jiangsu, China
Novartis Investigative Site
Xuzhou, Jiangsu, China
Novartis Investigative Site
Changchun, Jilin, China
Novartis Investigative Site
Changchun, Jilin, China
Novartis Investigative Site
Jinan, Shandong, China
Novartis Investigative Site
Jinshan, Shanghai Municipality, China
Novartis Investigative Site
Taiyuan, Shanxi, China
Novartis Investigative Site
Xian, Shanxi, China
Novartis Investigative Site
Tianjin, Tianjin Municipality, China
Novartis Investigative Site
Hangzhou, Zhejiang, China
Novartis Investigative Site
Beijing, China
Novartis Investigative Site
Beijing, China
Novartis Investigative Site
Beijing, China
Novartis Investigative Site
Beijing, China
Novartis Investigative Site
Shanghai, China
Novartis Investigative Site
Shanghai, China
Novartis Investigative Site
Shanghai, China
Novartis Investigative Site
Shanghai, China
Novartis Investigative Site
Tianjin, China
Novartis Investigative Site
Tianjin, China
Novartis Investigative Site
Xiamen, China
Novartis Investigative Site
Singapore, Singapore
Novartis Investigative Site
Singapore, Singapore
Novartis Investigative Site
Wŏnju, Gangwon-do, South Korea
Novartis Investigative Site
Incheon, Korea, South Korea
Novartis Investigative Site
Seoul, Korea, South Korea
Novartis Investigative Site
Seoul, Korea, South Korea
Novartis Investigative Site
Seoul, Seoul, South Korea
Novartis Investigative Site
Seoul, South Korea, South Korea
Novartis Investigative Site
Gwangju, South Korea
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Kaohsiung City, Taiwan
Novartis Investigative Site
Taipei, Taiwan
Novartis Investigative Site
Taipei, Taiwan
Novartis Investigative Site
Taipei, Taiwan