NOVARTIS-CKJX839A12305 (MDCO-PCS-17-08)

Study Sponsor: Novartis

Study Title

A Placebo-Controlled, Double-Blind, Randomized Trial to Evaluate the Effect of 300 mg of Inclisiran Sodium Given as Subcutaneous Injections in Subjects With Atherosclerotic Cardiovascular Disease (ASCVD) or ACSVD Risk-Equivalents and Elevated Low-Density Lipoprotein Cholesterol (LDL-C)

Medicine or Vaccine (generic name)

inclisiran

Sponsor Identification Number

CKJX839A12305 (MDCO-PCS-17-08)

Trial Registry Identification Number(#'s)

NCT03400800

Medical Condition

ASCVD;
Risk Factor, Cardiovascular;
Elevated Cholesterol

Phase

Phase 3

Link to study details on the Novartis Clinical Study Register

Link to study details on ClinicalTrials.gov (if available)

https://classic.clinicaltrials.gov/ct2/show/record/NCT03400800?term=MDCO-PCS-17-08&draw=1&rank=1

Link to study details on EudraCT (if available)

https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-001846-90/results

Datasets and Documents Available for this Study

Raw dataset	Annotated case report form	Dataset specifications	Protocol with any amendments
Analysis-ready dataset	Reporting and analysis plan	Clinical study report	Ready to Share

Additional information about the data and documents available for this study

Date Added to this Site

December 2023