CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,561 enrolled
Drug / intervention
Inclisiran Sodium +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03399370
NCT03399370Phase 3Completed
CompareCT.gov

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) and Elevated Low-Density Lipoprotein Cholesterol (LDL-C)

The Medicines Company·interventional·Posted Jan 16, 2018·Updated Oct 5, 2020

In Brief

A Phase 3 clinical trial evaluating Inclisiran Sodium and Placebo for ASCVD and Elevated Cholesterol. Completed, enrolled 1,561 participants across 145 sites.

Detailed Summary

This is a Phase III, placebo-controlled, double-blind, randomized study in participants with ASCVD 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 a multicenter study in the United States.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsASCVD, Elevated Cholesterol
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedJan 16, 2018
Enrollment StartDec 21, 2017
Primary CompletionSep 10, 2019
Study CompletionSep 17, 2019
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 8.5 years ago

Interventions

Inclisiran Sodiumdrug

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

Placebodrug

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