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

NCT03814187 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3275

Last updated 2024-03-06

Study results available
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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.

Conditions

  • ASCVD
  • Elevated Cholesterol
  • Heterozygous Familial Hypercholesterolemia
  • Homozygous Familial Hypercholesterolemia

Interventions

DRUG

Inclisiran Sodium

Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.

Sponsors & Collaborators

Principal Investigators

  • Scott Wright, MD · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-16
Primary Completion
2023-02-13
Completion
2023-02-13
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Czechia
  • Denmark
  • Germany
  • Hungary
  • Netherlands
  • Poland
  • South Africa
  • Spain
  • Sweden
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03814187 on ClinicalTrials.gov