Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) When Co-administered With High Dose of Atorvastatin in Patients With Primary Hypercholesterolemia
Public ClinicalTrials.gov record NCT01288469. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-blind, Parallel-group, Placebo-controlled, Fixed Dose/Dose Regimen, Multicenter Study Evaluating the Efficacy and Safety of SAR236553 When Co-administered With 80 mg of Atorvastatin Over 8 Weeks in Patients With Primary Hypercholesterolemia and LDL-cholesterol ≥ 100 mg/dL (≥2.59 mmol/L) on Atorvastatin 10 mg
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Primary Objective: To evaluate the effect of alirocumab (SAR236553/REGN727) on low-density lipoprotein cholesterol (LDL-C) levels compared with placebo when co-administered with 80 mg of atorvastatin after 8 weeks of treatment in participants with LDL-C ≥ 100mg/dL (≥ 2.59 mmol/L) on atorvastatin 10 mg. Secondary Objectives: * To evaluate the effects of alirocumab on other lipid levels in comparison with placebo, when co-administered with 80 mg of atorvastatin after 8 weeks of treatment. * To evaluate the efficacy of alirocumab when co-administered with a high dose of atorvastatin (80 mg) versus atorvastatin 10 mg. * To evaluate the safety and tolerability of alirocumab when co-administered with 2 different doses of atorvastatin. * To evaluate the development of anti-alirocumab antibodies. * To evaluate the pharmacokinetics of alirocumab.
Study identification
- NCT ID
- NCT01288469
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 92 participants
Conditions and interventions
Conditions
Interventions
- Alirocumab Drug
- Placebo (for alirocumab) Drug
- Atorvastatin Drug
- Placebo (for atorvastatin) Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 2010
- Primary completion
- Aug 31, 2011
- Completion
- Aug 31, 2011
- Last update posted
- Sep 23, 2015
2011
United States locations
- U.S. sites
- 20
- U.S. states
- 11
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 840616 | Mesa | Arizona | 85206 | — |
| Investigational Site Number 840601 | Tucson | Arizona | 85710 | — |
| Investigational Site Number 840610 | Los Angeles | California | 90057 | — |
| Investigational Site Number 840608 | Newport Beach | California | 92660 | — |
| Investigational Site Number 840603 | Doral | Florida | 33166 | — |
| Investigational Site Number 840611 | Jacksonville | Florida | 32223 | — |
| Investigational Site Number 840618 | Jupiter | Florida | 33458 | — |
| Investigational Site Number 840612 | Miami | Florida | 33138 | — |
| Investigational Site Number 840614 | Miami | Florida | 33138 | — |
| Investigational Site Number 840607 | St. Petersburg | Florida | 33609 | — |
| Investigational Site Number 840605 | Chicago | Illinois | 60610 | — |
| Investigational Site Number 840619 | Chicago | Illinois | 60610 | — |
| Investigational Site Number 840604 | Edison | New Jersey | 08817 | — |
| Investigational Site Number 840606 | Rochester | New York | 14609 | — |
| Investigational Site Number 840615 | Cincinnati | Ohio | 45219 | — |
| Investigational Site Number 840617 | Cincinnati | Ohio | 45219 | — |
| Investigational Site Number 840602 | Eugene | Oregon | 97404 | — |
| Investigational Site Number 840621 | Richmond | Virginia | 23227 | — |
| Investigational Site Number 840609 | Olympia | Washington | 98502 | — |
| Investigational Site Number 840613 | Oregon | Wisconsin | 53575 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01288469, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 23, 2015 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01288469 live on ClinicalTrials.gov.