Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) in Patients With Primary Hypercholesterolemia on Stable Atorvastatin Therapy
Public ClinicalTrials.gov record NCT01288443. 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, Multicenter Study Evaluating the Efficacy and Safety of Five Doses and Two Dose Regimens of SAR236553 Over 12 Weeks in Patients With Primary Hypercholesterolemia and LDL-cholesterol ≥ 100 mg/dL (≥ 2.59 mmol/L) on Ongoing Stable Atorvastatin Therapy
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 after 12 weeks of treatment in comparison with placebo in participants with LDL-C ≥ 100 mg/dL (≥ 2.59 mmol/L) on ongoing stable atorvastatin therapy. Secondary Objectives: * To evaluate the effects of alirocumab on other lipid levels after 12 weeks of treatment in comparison with placebo * To evaluate the safety and tolerability of alirocumab * To evaluate the development of anti-alirocumab antibodies * To evaluate the pharmacokinetics of alirocumab
Study identification
- NCT ID
- NCT01288443
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 183 participants
Conditions and interventions
Conditions
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
- Jan 2011 (Type not available)
- Primary completion
- Dec 2011 (Actual)
- Completion
- Dec 2011 (Actual)
- Last update posted
- Sep 24, 2015
2011
United States locations
- U.S. sites
- 38
- U.S. states
- 21
- U.S. cities
- 36
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 840525 | Tempe | Arizona | 85282 | — |
| Investigational Site Number 840516 | Los Angeles | California | 90057 | — |
| Investigational Site Number 840528 | Mission Viejo | California | 92691 | — |
| Investigational Site Number 840509 | Newport Beach | California | 92660 | — |
| Investigational Site Number 840523 | Palm Springs | California | 92262 | — |
| Investigational Site Number 840534 | Westlake Village | California | 91361 | — |
| Investigational Site Number 840530 | Colorado Springs | Colorado | 80903 | — |
| Investigational Site Number 840504 | Aventura | Florida | 33108 | — |
| Investigational Site Number 840519 | Aventura | Florida | 33108 | — |
| Investigational Site Number 840514 | Jacksonville | Florida | 32216 | — |
| Investigational Site Number 840539 | Jupiter | Florida | 33458 | — |
| Investigational Site Number 840502 | Miami | Florida | 33143 | — |
| Investigational Site Number 840520 | Pembroke Pines | Florida | 33026 | — |
| Investigational Site Number 840524 | Ponte Vedra | Florida | 32081 | — |
| Investigational Site Number 840536 | Port Orange | Florida | 32127 | — |
| Investigational Site Number 840507 | St. Petersburg | Florida | 33609 | — |
| Investigational Site Number 840527 | Chicago | Illinois | 60611 | — |
| Investigational Site Number 840506 | Evansville | Indiana | 47714 | — |
| Investigational Site Number 840529 | Indianapolis | Indiana | 46260 | — |
| Investigational Site Number 840515 | Wichita | Kansas | 67203 | — |
| Investigational Site Number 840532 | Madisonville | Kentucky | 42431 | — |
| Investigational Site Number 840535 | Auburn | Maine | 04210 | — |
| Investigational Site Number 840503 | Brockton | Massachusetts | 02301 | — |
| Investigational Site Number 840512 | Las Vegas | Nevada | 89123 | — |
| Investigational Site Number 840505 | Edison | New Jersey | 08817 | — |
| Investigational Site Number 840538 | Rochester | New York | 14609 | — |
| Investigational Site Number 840508 | Raleigh | North Carolina | 27612 | — |
| Investigational Site Number 840522 | Statesville | North Carolina | 28677 | — |
| Investigational Site Number 840511 | Cincinnati | Ohio | 45219 | — |
| Investigational Site Number 840526 | Cincinnati | Ohio | 45219 | — |
| Investigational Site Number 840510 | Lyndhurst | Ohio | 44124 | — |
| Investigational Site Number 840533 | Tulsa | Oklahoma | 74136 | — |
| Investigational Site Number 840537 | Eugene | Oregon | 97404 | — |
| Investigational Site Number 840521 | Bristol | Tennessee | 37620 | — |
| Investigational Site Number 840531 | Bountiful | Utah | 84010 | — |
| Investigational Site Number 840517 | Norfolk | Virginia | 23502 | — |
| Investigational Site Number 840518 | Richmond | Virginia | 23227 | — |
| Investigational Site Number 840513 | Olympia | Washington | 98502 | — |
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 NCT01288443, 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 24, 2015 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01288443 live on ClinicalTrials.gov.