MedTrace Logo

Inclisiran for Subjects With ASCVD or ASCVD-Risk Equivalents and Elevated Low-density Lipoprotein Cholesterol

NCT03400800 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1617

Last updated 2020-08-21

Study results available
· View outcomes & findings →

Summary

This is a Phase III, placebo-controlled, double-blind, randomized study in participants with ASCVD or ASCVD-Risk equivalents and elevated LDL-C despite maximum tolerated dose of LDL-C lowering therapies to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) inclisiran injection(s). The study will be an international multicenter study (non-United States).

Conditions

  • ASCVD
  • Risk Factor, Cardiovascular
  • Elevated Cholesterol

Interventions

DRUG

Inclisiran Sodium

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

DRUG

Placebo

Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection).

Sponsors & Collaborators

  • The Medicines Company

    lead INDUSTRY

Principal Investigators

  • Ray Kausik, MD · Imperial College of London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2019-07-31
Completion
2019-08-27
FDA Drug
Yes

Countries

  • Czechia
  • Germany
  • Hungary
  • Poland
  • South Africa
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT03400800 on ClinicalTrials.gov