Phase III Study To Evaluate Alirocumab in Patients With Hypercholesterolemia Not Treated With a Statin (ODYSSEY CHOICE II)
Public ClinicalTrials.gov record NCT02023879. 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 Evaluating the Efficacy and Safety of Alirocumab in Patients With Primary Hypercholesterolemia Not Treated With a Statin
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Primary Objective: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by a regimen of Alirocumab including a starting dose of 150 mg every 4 weeks (Q4W) as add-on to non-statin lipid modifying background therapy or as monotherapy in comparison with placebo in participants with primary hypercholesterolemia not treated with a statin. Secondary Objective: * To evaluate the effects on other lipid parameters of Alirocumab 150 mg Q4W versus placebo. * To evaluate the safety and tolerability of Alirocumab 150 mg Q4W. Alirocumab 75 mg Q2W was added as a calibrator arm.
Study identification
- NCT ID
- NCT02023879
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 233 participants
Conditions and interventions
Conditions
Interventions
- Alirocumab Drug
- Placebo (for Alirocumab) Drug
- Non-statin LMT Drug
- Diet Alone Other
Drug · Other
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
- Dec 15, 2013
- Primary completion
- Oct 26, 2014
- Completion
- Jun 29, 2017
- Last update posted
- Jul 26, 2018
2013 – 2017
United States locations
- U.S. sites
- 8
- U.S. states
- 6
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 840703 | Beverly Hills | California | 90211 | — |
| Investigational Site Number 840704 | Atlantis | Florida | 33462 | — |
| Investigational Site Number 840708 | Jacksonville | Florida | 32216 | — |
| Investigational Site Number 840701 | Sarasota | Florida | 34239 | — |
| Investigational Site Number 840706 | Fall River | Massachusetts | 02720 | — |
| Investigational Site Number 840705 | St Louis | Missouri | 63131 | — |
| Investigational Site Number 840707 | Durham | North Carolina | 27710 | — |
| Investigational Site Number 840702 | Summerville | South Carolina | 29485 | — |
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 35 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02023879, 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 Jul 26, 2018 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02023879 live on ClinicalTrials.gov.