At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 2,176 enrolled
Drug / intervention
Praluent (Alirocumab) +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.
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Praluent on Neurocognitive Function in Patients With Heterozygous Familial Hypercholesterolemia or With Non-Familial Hypercholesterolemia at High and Very High Cardiovascular Risk
In Brief
A Phase 4 clinical trial evaluating Praluent (Alirocumab) and Placebo for Hypercholesterolemia. Completed, enrolled 2,176 participants across 188 sites in 9 countries.
Detailed Summary
The main purpose of this study is to evaluate the effect on mental state (known as "neurocognitive function") with use of Praluent.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypercholesterolemia
CountriesBulgaria, Chile, Estonia, Japan, Mexico, Russia, South Africa, Ukraine, United States
CollaboratorsSanofi
Timeline
Phase 4CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartNov 2016
First PostedNov 2016
Primary CompletionMar 2020
TodayJul 2026
First PostedNov 8, 2016
Enrollment StartNov 2, 2016
Primary CompletionMar 5, 2020
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 9.7 years ago
Interventions
Praluent (Alirocumab)drug
Placebodrug