Trial to Assess the Effect of Long Term Dosing of Inclisiran in Subjects With High CV Risk and Elevated LDL-C

Novartis Pharmaceuticals

Source: ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters. Not a U.S. Government endorsement.

Brief summary

The purpose of this extension study was to evaluate the efficacy, safety, and tolerability of long-term dosing of Inclisiran. The study was a global multicenter study.

Source: ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters. Not a U.S. Government endorsement.

Trial details

acronym
ORION-8
status
COMPLETED
phase
PHASE3
study type
INTERVENTIONAL
enrollment
3275
sponsor
Novartis Pharmaceuticals
conditions
ASCVD; Elevated Cholesterol; Heterozygous Familial Hypercholesterolemia; Homozygous Familial Hypercholesterolemia
interventions
DRUG: Inclisiran Sodium
start date
2019-04-16
start date type
ACTUAL
primary completion date
2023-02-13
has results
true
data source
ClinicalTrials.gov
data processed
2026-10-29T09:00:05
modifications
selected fields only; whitespace normalized; brief summary truncated to 2,000 characters

Record

Archive ID
nct:NCT03814187
Published
Jan 23, 2019
Updated
Mar 6, 2024
Venue
ClinicalTrials.gov
ClinicalTrials.gov
NCT03814187
Categories
ASCVD, Elevated Cholesterol, Heterozygous Familial Hypercholesterolemia, Homozygous Familial Hypercholesterolemia
License
ClinicalTrials.gov terms (attribution, processing date, modifications noted)
Provenance
clinicaltrials

Topics