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ACTIVE NOT RECRUITING
NCT04765657
PHASE3

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

View on ClinicalTrials.gov

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

Interventions

DRUG

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)

DRUG

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