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Completed Phase 3 Interventional Results available

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)

ClinicalTrials.gov ID: NCT01709513

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.

ClinicalTrials.gov public records Last synced May 5, 2026, 2:37 AM EDT

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

Study identification

NCT ID
NCT01709513
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Regeneron Pharmaceuticals
Industry
Enrollment
314 participants

Conditions and interventions

Interventions

  • Alirocumab Drug
  • Atorvastatin Drug
  • Ezetimibe Drug
  • Placebo Drug

Drug

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 29, 2012
Primary completion
May 30, 2014
Completion
May 30, 2017
Last update posted
Jun 22, 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 22, 2020 · Synced May 5, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01709513 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →