At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 305 enrolled
Drug / intervention
Alirocumab +3 moredrug
Likely dose
Alirocumab 1 mLfrom 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 Study of the Efficacy and Safety of REGN727 Added-on to Rosuvastatin Versus Ezetimibe Added-on to Rosuvastatin Versus Rosuvastatin Dose Increase in Patients Who Are Not Controlled on Rosuvastatin
In Brief
A Phase 3 clinical trial evaluating Alirocumab, Rosuvastatin, and 2 other interventions for Hypercholesterolemia. Completed, enrolled 305 participants across 93 sites in 9 countries.
Detailed Summary
To evaluate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab (REGN727/SAR236553) as an add-on therapy to other LMT in patients with hypercholesterolemia at high cardiovascular (CV) risk.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypercholesterolemia
CountriesAustralia, Canada, France, Germany, Italy, Mexico, Spain, United Kingdom, United States
CollaboratorsSanofi
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 2012
Enrollment StartNov 2012
Primary CompletionApr 2014
Study CompletionMay 2014
TodayJul 2026
First PostedNov 21, 2012
Enrollment StartNov 30, 2012
Primary CompletionApr 30, 2014
Study CompletionMay 31, 2014
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 13.6 years ago
Interventions
Alirocumabdrug
Alirocumab administered as a SC injection of 1 mL into the abdomen, thigh, or outer area of the upper arm.
Rosuvastatindrug
Rosuvastatin over-encapsulated tablets orally.
Ezetimibedrug
Ezetimibe over-encapsulated tablets orally.
Placebodrug
Placebo for alirocumab and ezetimibe.