At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 3,275 enrolled
Drug / intervention
Inclisiran Sodiumdrug
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.
An Open-label Extension Trial of the Phase III Lipid-lowering Trials to Assess the Effect of Long Term Dosing of Inclisiran Given as Subcutaneous Injections in Subjects With High Cardiovascular Risk and Elevated LDL-C
In Brief
A Phase 3 clinical trial evaluating Inclisiran Sodium for ASCVD and 3 related conditions. Completed, enrolled 3,275 participants across 238 sites in 13 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsASCVD, Elevated Cholesterol, Heterozygous Familial Hypercholesterolemia, Homozygous Familial Hypercholesterolemia
CountriesCanada, Czechia, Denmark, Germany, Hungary, Netherlands, Poland, South Africa, Spain, Sweden, Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJan 2019
Enrollment StartApr 2019
Primary CompletionFeb 2023
TodayJul 2026
First PostedJan 23, 2019
Enrollment StartApr 16, 2019
Primary CompletionFeb 13, 2023
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 7.4 years ago
Interventions
Inclisiran Sodiumdrug
Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.