Durable Effect of PCSK9 Antibody CompARed wiTh placEbo Study
Public ClinicalTrials.gov record NCT01516879. 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 Double-Blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Long-Term Tolerability and Durable Efficacy of AMG 145 (Evolocumab) on LDL-C in Hyperlipidemic Subjects
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
To evaluate the efficacy, safety, and tolerability of 52 weeks of subcutaneous (SC) evolocumab (AMG 145) compared with placebo when added to assigned background lipid-lowering therapy.
Study identification
- NCT ID
- NCT01516879
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 905 participants
Conditions and interventions
Conditions
Interventions
- Evolocumab Biological
- Placebo Biological
- Atorvastatin Drug
- Ezetimibe Drug
- Diet Only Other
Biological · Drug · Other
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- 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
- Jan 5, 2012 (Actual)
- Primary completion
- Oct 14, 2013 (Actual)
- Completion
- Oct 14, 2013 (Actual)
- Last update posted
- Jul 22, 2022
2012 – 2013
United States locations
- U.S. sites
- 41
- U.S. states
- 25
- U.S. cities
- 36
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Birmingham | Alabama | 35216 | — |
| Research Site | Little Rock | Arkansas | 72205 | — |
| Research Site | Anaheim | California | 92801 | — |
| Research Site | Encinitas | California | 92024 | — |
| Research Site | Spring Valley | California | 91978 | — |
| Research Site | Westlake Village | California | 91361 | — |
| Research Site | DeLand | Florida | 32720 | — |
| Research Site | Jacksonville | Florida | 32204 | — |
| Research Site | Jacksonville | Florida | 32216 | — |
| Research Site | Ponte Vedra | Florida | 32081 | — |
| Research Site | Atlanta | Georgia | 30338 | — |
| Research Site | Atlanta | Georgia | 30342 | — |
| Research Site | Savannah | Georgia | 31406 | — |
| Research Site | Chicago | Illinois | 60610 | — |
| Research Site | Indianapolis | Indiana | 46260 | — |
| Research Site | Louisville | Kentucky | 40213 | — |
| Research Site | Auburn | Maine | 04210 | — |
| Research Site | Bethesda | Maryland | 20817 | — |
| Research Site | Chevy Chase | Maryland | 20815 | — |
| Research Site | Columbia | Maryland | 21045 | — |
| Research Site | Brockton | Massachusetts | 02301 | — |
| Research Site | Saint Paul | Minnesota | 55114 | — |
| Research Site | Olive Branch | Mississippi | 38654 | — |
| Research Site | Las Vegas | Nevada | 89148 | — |
| Research Site | Endwell | New York | 13760 | — |
| Research Site | New Windsor | New York | 12553 | — |
| Research Site | Raleigh | North Carolina | 27609 | — |
| Research Site | Raleigh | North Carolina | 27612 | — |
| Research Site | Fargo | North Dakota | 58103 | — |
| Research Site | Akron | Ohio | 44311 | — |
| Research Site | Cincinnati | Ohio | 45219 | — |
| Research Site | Cincinnati | Ohio | 45227 | — |
| Research Site | Cincinnati | Ohio | 45246 | — |
| Research Site | Norman | Oklahoma | 73069 | — |
| Research Site | Duncansville | Pennsylvania | 16635 | — |
| Research Site | Mt. Pleasant | South Carolina | 29464 | — |
| Research Site | Rapid City | South Dakota | 57702 | — |
| Research Site | Houston | Texas | 77030 | — |
| Research Site | Richmond | Virginia | 23294 | — |
| Research Site | Renton | Washington | 98057 | — |
| Research Site | Seattle | Washington | 98104 | — |
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 55 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01516879, 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 22, 2022 · Synced Oct 18, 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 NCT01516879 live on ClinicalTrials.gov.