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Completed Phase 3 Interventional Results available

Study of Alirocumab (REGN727/SAR236553) added-on to Rosuvastatin Versus Other Lipid Modifying Treatments (LMT) (ODYSSEY OPTIONS II)

ClinicalTrials.gov ID: NCT01730053

Public ClinicalTrials.gov record NCT01730053. 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 Oct 16, 2026, 10:07 PM 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 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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT01730053
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Regeneron Pharmaceuticals
Industry
Enrollment
305 participants

Conditions and interventions

Interventions

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
Nov 30, 2012 (Actual)
Primary completion
Apr 30, 2014 (Actual)
Completion
May 31, 2014 (Actual)
Last update posted
Apr 7, 2020

2012 – 2014

United States locations

U.S. sites
54
U.S. states
23
U.S. cities
54
Facility City State ZIP Site status
Not listed Chandler Arizona — —
Not listed Tucson Arizona — —
Not listed Anaheim California — —
Not listed Beverly Hills California — —
Not listed Fair Oaks California — —
Not listed Newport Beach California — —
Not listed Northridge California — —
Not listed Sacramento California — —
Not listed Walnut Creek California — —
Not listed Milford Connecticut — —
Not listed Atlantis Florida — —
Not listed Bradenton Florida — —
Not listed Clearwater Florida — —
Not listed Fort Lauderdale Florida — —
Not listed Jacksonville Florida — —
Not listed Lakeland Florida — —
(2 Locations) Miami Florida — —
Not listed Oviedo Florida — —
Not listed Pinellas Park Florida — —
Not listed Port Orange Florida — —
Not listed Sarasota Florida — —
Not listed Tampa Florida — —
Not listed West Palm Beach Florida — —
Not listed Winter Park Florida — —
Not listed Boise Idaho — —
Not listed Morton Illinois — —
Not listed Evansville Indiana — —
Not listed Indianapolis Indiana — —
Not listed Newton Kansas — —
Not listed Overland Park Kansas — —
Not listed Wichita Kansas — —
Not listed Lexington Kentucky — —
Not listed Louisville Kentucky — —
Not listed Auburn Maine — —
Not listed Bethesda Maryland — —
Not listed Edina Minnesota — —
Not listed Rochester Minnesota — —
Not listed Olive Branch Mississippi — —
Not listed Port Gibson Mississippi — —
Not listed St Louis Missouri — —
Not listed Butte Montana — —
Not listed Williamsville New York — —
Not listed Cincinnati Ohio — —
Not listed Marion Ohio — —
Not listed Portland Oregon — —
Not listed Warwick Rhode Island — —
Not listed Greer South Carolina — —
Not listed Summerville South Carolina — —
Not listed Kingsport Tennessee — —
Not listed Dallas Texas — —
Not listed Fort Worth Texas — —
Not listed Houston Texas — —
Not listed Bountiful Utah — —
Not listed Salt Lake City Utah — —

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 39 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01730053, 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 Apr 7, 2020 · Synced Oct 16, 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 public registry record, listed eligibility criteria, and available contact information for NCT01730053 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →