Study of Alirocumab (REGN727/SAR236553) in Patients With Primary Hypercholesterolemia and Moderate, High, or Very High Cardiovascular (CV) Risk, Who Are Intolerant to Statins (ODYSSEY ALTERNATIVE)
Public ClinicalTrials.gov record NCT01709513. 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, Double-Dummy, Active-Controlled Study to Evaluate the Efficacy and Safety of REGN727/SAR236553 in Patients With Primary Hypercholesterolemia Who Are Intolerant to Statins
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a randomized, double-blind, double-dummy, active-controlled, parallel-group, multi-national, multi-center study to compare alirocumab (REGN727/SAR236553) versus ezetimibe in participants with primary hypercholesterolemia and moderate, high, or very high CV risk, who are intolerant to statins. An atorvastatin arm is added to determine that the population selected in the study is a truly statin intolerant population by assessing skeletal muscle-related adverse events.
Study identification
- NCT ID
- NCT01709513
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 314 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- 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
- Sep 30, 2012 (Actual)
- Primary completion
- May 31, 2014 (Actual)
- Completion
- May 31, 2017 (Actual)
- Last update posted
- Jun 23, 2020
2012 – 2017
United States locations
- U.S. sites
- 41
- U.S. states
- 20
- U.S. cities
- 41
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Anaheim | California | — | — |
| Not listed | Beverly Hills | California | — | — |
| Not listed | Mission Viejo | California | — | — |
| Not listed | Newport Beach | California | — | — |
| Not listed | Northridge | California | — | — |
| Not listed | Thousand Oaks | California | — | — |
| Not listed | Hartford | Connecticut | — | — |
| Not listed | Boynton Beach | Florida | — | — |
| Not listed | Jacksonville | Florida | — | — |
| Not listed | Lakeland | Florida | — | — |
| Not listed | Pembroke Pines | Florida | — | — |
| Not listed | Sarasota | Florida | — | — |
| Not listed | Tampa | Florida | — | — |
| Not listed | Trinity | Florida | — | — |
| Not listed | Addison | Illinois | — | — |
| Not listed | Chicago | Illinois | — | — |
| Not listed | Indianapolis | Indiana | — | — |
| Not listed | Kansas City | Kansas | — | — |
| Not listed | Auburn | Maine | — | — |
| Not listed | Boston | Massachusetts | — | — |
| Not listed | Minneapolis | Minnesota | — | — |
| Not listed | Rochester | Minnesota | — | — |
| Not listed | St Louis | Missouri | — | — |
| Not listed | Clifton | New Jersey | — | — |
| Not listed | New York | New York | — | — |
| Not listed | Poughkeepsie | New York | — | — |
| Not listed | Durham | North Carolina | — | — |
| Not listed | Cincinnati | Ohio | — | — |
| Not listed | Marion | Ohio | — | — |
| Not listed | Danville | Pennsylvania | — | — |
| Not listed | Philadelphia | Pennsylvania | — | — |
| Not listed | Port Matilda | Pennsylvania | — | — |
| Not listed | Scranton | Pennsylvania | — | — |
| Not listed | Wilkes-Barre | Pennsylvania | — | — |
| Not listed | Summerville | South Carolina | — | — |
| Not listed | Kingsport | Tennessee | — | — |
| Not listed | Nashville | Tennessee | — | — |
| Not listed | Dallas | Texas | — | — |
| Not listed | Fort Worth | Texas | — | — |
| Not listed | Salt Lake City | Utah | — | — |
| Not listed | Richmond | Virginia | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 29 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01709513, 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 Jun 23, 2020 · Synced Oct 16, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01709513 live on ClinicalTrials.gov.