Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia (ODYSSEY HIGH FH)
Public ClinicalTrials.gov record NCT01617655. 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, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of SAR236553/REGN727 in Patients With Heterozygous Familial Hypercholesterolemia and LDL-C Higher or Equal to 160mg/dL With Their Lipid-Modifying Therapy
Study identification
- NCT ID
- NCT01617655
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Sanofi
- Industry
- Enrollment
- 107 participants
Conditions and interventions
Conditions
Interventions
- Alirocumab Drug
- Lipid Modifying Therapy (LMT) Drug
- Placebo (for alirocumab) 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
- May 31, 2012
- Primary completion
- Apr 30, 2014
- Completion
- Dec 31, 2014
- Last update posted
- Oct 3, 2016
2012 – 2015
United States locations
- U.S. sites
- 14
- U.S. states
- 8
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 840742 | Bell Gardens | California | 90201 | — |
| Investigational Site Number 840703 | Newport Beach | California | 92660 | — |
| Investigational Site Number 840712 | Newport Beach | California | 92663 | — |
| Investigational Site Number 840743 | Northridge | California | 91324 | — |
| Investigational Site Number 840734 | Washington D.C. | District of Columbia | 20037 | — |
| Investigational Site Number 840738 | Miami | Florida | 33165 | — |
| Investigational Site Number 840710 | Ponte Vedra | Florida | 32081 | — |
| Investigational Site Number 840701 | New York | New York | 10032 | — |
| Investigational Site Number 840702 | Durham | North Carolina | 27710 | — |
| Investigational Site Number 840714 | Cincinnati | Ohio | 45219 | — |
| Investigational Site Number 840705 | Philadelphia | Pennsylvania | 19104 | — |
| Investigational Site Number 840709 | Philadelphia | Pennsylvania | 19104 | — |
| Investigational Site Number 840713 | Philadelphia | Pennsylvania | 19104 | — |
| Investigational Site Number 840736 | Dallas | Texas | 75216 | — |
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 21 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01617655, 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 Oct 3, 2016 · Synced May 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01617655 live on ClinicalTrials.gov.