ClinicalTrials.gov record
Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol
ClinicalTrials.gov ID: NCT03399370
Public ClinicalTrials.gov record NCT03399370. 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 Placebo-Controlled, Double-Blind, Randomized Trial to Evaluate the Effect of 300 mg of Inclisiran Sodium Given as Subcutaneous Injections in Subjects With Atherosclerotic Cardiovascular Disease (ASCVD) and Elevated Low-Density Lipoprotein Cholesterol (LDL-C)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase III, placebo-controlled, double-blind, randomized study in participants with ASCVD and elevated LDL-C despite maximum tolerated dose of LDL-C lowering therapies to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) inclisiran injection(s). The study will be a multicenter study in the United States.
Study identification
- NCT ID
- NCT03399370
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,561 participants
Conditions and interventions
Conditions
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 21, 2017 (Actual)
- Primary completion
- Sep 10, 2019 (Actual)
- Completion
- Sep 17, 2019 (Actual)
- Last update posted
- Oct 5, 2020
2017 – 2019
United States locations
- U.S. sites
- 145
- U.S. states
- 29
- U.S. cities
- 113
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site 10001-015 | Birmingham | Alabama | 35211 | — |
| Research Site 10001-138 | Foley | Alabama | 36535 | — |
| Research Site 10001-113 | Huntsville | Alabama | 35801 | — |
| Research Site 10001-058 | Mobile | Alabama | 36608 | — |
| Research Site 10001-037 | Montgomery | Alabama | 36117 | — |
| Research Site 10001-076 | Saraland | Alabama | 36571 | — |
| Research Site 10001-013 | Chandler | Arizona | 85224 | — |
| Research Site 10001-077 | Mesa | Arizona | 85213 | — |
| Research Site 10001-136 | Phoenix | Arizona | 85014 | — |
| Research Site 10001-051 | Surprise | Arizona | 85374 | — |
| Research Site 10001-019 | Tucson | Arizona | 85712 | — |
| Research Site 10001-004 | Tucson | Arizona | 85741 | — |
| Research Site 10001-132 | Tucson | Arizona | 85745 | — |
| Research Site 10001-073 | Beverly Hills | California | 90211 | — |
| Research Site 10001-050 | Canoga Park | California | 91303 | — |
| Research Site 10001-011 | Carlsbad | California | 92008 | — |
| Research Site 10001-065 | El Cajon | California | 92020 | — |
| Research Site 10001-150 | Los Angeles | California | 90022 | — |
| Research Site 10001-043 | Northridge | California | 91324 | — |
| Research Site 10001-022 | Northridge | California | 91325 | — |
| Research Site 10001-033 | Sacramento | California | 95821-2134 | — |
| Research Site 10001-105 | San Ramon | California | 94582 | — |
| Research Site 10001-008 | Santa Rosa | California | 95405 | — |
| Research Site 10001-153 | Spring Valley | California | 91978 | — |
| Research Site 10001-044 | Torrance | California | 90502 | — |
| Research Site 10001-047 | Boca Raton | Florida | 33434 | — |
| Research Site 10001-084 | Clearwater | Florida | 33756 | — |
| Research Site 10001-155 | Clearwater | Florida | 33756 | — |
| Research Site 10001-099 | Clearwater | Florida | 33761 | — |
| Research Site 10001-127 | Daytona Beach | Florida | 32117 | — |
| Research Site 10001-119 | Fleming Island | Florida | 32003 | — |
| Research Site 10001-070 | Fort Lauderdale | Florida | 33308 | — |
| Research Site 10001-067 | Hialeah | Florida | 33012 | — |
| Research Site 10001-139 | Jacksonville | Florida | 32204 | — |
| Research Site 10001-039 | Jacksonville | Florida | 32216 | — |
| Research Site 10001-098 | Jacksonville | Florida | 32216 | — |
| Research Site 10001-081 | Miami | Florida | 33126 | — |
| Research Site 10001-140 | Miami | Florida | 33126 | — |
| Research Site 10001-142 | Miami | Florida | 33126 | — |
| Research Site 10001-030 | Miami | Florida | 33165 | — |
| Research Site 10001-089 | Miami | Florida | 33173 | — |
| Research Site 10001-116 | Miami | Florida | 33183 | — |
| Research Site 10001-080 | Miami Springs | Florida | 33166 | — |
| Research Site 10001-027 | Pembroke Pines | Florida | 33024 | — |
| Research Site 10001-115 | Pembroke Pines | Florida | 33027 | — |
| Research Site 10001-048 | Pembroke Pines | Florida | 33029 | — |
| Research Site 10001-147 | Pembroke Pines | Florida | 33029 | — |
| Research Site 10001-003 | Pinellas Park | Florida | 33781 | — |
| Research Site 10001-104 | Ponte Vedra | Florida | 32081 | — |
| Research Site 10001-090 | Saint Augustine | Florida | 32086 | — |
| Research Site 10001-123 | Sarasota | Florida | 34239-3513 | — |
| Research Site 10001-102 | St. Petersburg | Florida | 33713 | — |
| Research Site 10001-038 | Tampa | Florida | 33607 | — |
| Research Site 10001-143 | Tampa | Florida | 33614 | — |
| Research Site 10001-069 | Atlanta | Georgia | 30342 | — |
| Research Site 10001-137 | Dunwoody | Georgia | 30338 | — |
| Research Site 10001-092 | Macon | Georgia | 31210 | — |
| Research Site 10001-059 | Arlington Heights | Illinois | 60005 | — |
| Research Site 10001-158 | Chicago | Illinois | 60602 | — |
| Research Site 10001-035 | Chicago | Illinois | 60616 | — |
| Research Site 10001-036 | Evanston | Illinois | 60201 | — |
| Research Site 10001-082 | Indianapolis | Indiana | 46260 | — |
| Research Site 1001-020 | Sellersburg | Indiana | 47172 | — |
| Research Site 10001-040 | Valparaiso | Indiana | 46383 | — |
| Research Site 10001-074 | West Des Moines | Iowa | 50266 | — |
| Research Site 10001-028 | Hutchinson | Kansas | 67502 | — |
| Research Site 10001-125 | Lexington | Kentucky | 40503 | — |
| Research Site 10001-108 | Lexington | Kentucky | 40504 | — |
| Research Site 10001-107 | Owensboro | Kentucky | 42303 | — |
| Research Site 10001-144 | Crowley | Louisiana | 70526 | — |
| Research Site 10001-041 | Lake Charles | Louisiana | 70601 | — |
| Research Site 10001-101 | Monroe | Louisiana | 71201 | — |
| Research Site 10001-024 | Flint | Michigan | 48504 | — |
| Research Site 10001-095 | Grandville | Michigan | 49418 | — |
| Research Site 10001-078 | Sterling Heights | Michigan | 48310 | — |
| Research Site 10001-034 | Troy | Michigan | 48098 | — |
| Research Site 10001-018 | Edina | Minnesota | 55435 | — |
| Research Site 10001-056 | Saint Paul | Minnesota | 55102 | — |
| Research Site 10001-156 | St Louis | Missouri | 63136 | — |
| Research Site 10001-007 | St Louis | Missouri | 63141 | — |
| Research Site 10001-053 | Omaha | Nebraska | 68134 | — |
| Research Site 10001-021 | Omaha | Nebraska | 68144 | — |
| Research Site 10001-112 | Las Vegas | Nevada | 89119 | — |
| Research Site 10001-124 | Las Vegas | Nevada | 89121 | — |
| Research Site 10001-060 | Bridgewater | New Jersey | 08807 | — |
| Research Site 10001-055 | Raritan | New Jersey | 08869 | — |
| Research Site 10001-054 | Albany | New York | 12206 | — |
| Research Site 10001-122 | Binghamton | New York | 13901 | — |
| Research Site 10001-128 | Endwell | New York | 13760 | — |
| Research Site 10001-042 | New Windsor | New York | 12553 | — |
| Research Site 10001-129 | Poughkeepsie | New York | 12601 | — |
| Research Site 10001-110 | Williamsville | New York | 14221 | — |
| Research Site 10001-063 | Cary | North Carolina | 27518 | — |
| Research Site 10001-064 | Greensboro | North Carolina | 27401 | — |
| Research Site 10001-145 | Mooresville | North Carolina | 28117 | — |
| Research Site 10001-046 | Shelby | North Carolina | 28150 | — |
| Research Site 10001-016 | Akron | Ohio | 443311 | — |
| Research Site 10001-120 | Cincinnati | Ohio | 45219 | — |
| Research Site 10001-154 | Cincinnati | Ohio | 45227 | — |
| Research Site 10001-010 | Cincinnati | Ohio | 45236 | — |
| Research Site 10001-134 | Cincinnati | Ohio | 45246 | — |
| Research Site 10001-014 | Columbus | Ohio | 43212 | — |
| Research Site 10001-012 | Columbus | Ohio | 43213 | — |
| Research Site 10001-141 | Dayton | Ohio | 45419 | — |
| Research Site 10001-148 | Marion | Ohio | 43302 | — |
| Research Site 10001-017 | Edmond | Oklahoma | 73003 | — |
| Research Site 10001-109 | Wyomissing | Pennsylvania | 19610 | — |
| Research Site 10001-001 | Anderson | South Carolina | 29621 | — |
| Research Site 10001-006 | Greer | South Carolina | 29651 | — |
| Research Site 10001-075. | Greer | South Carolina | 29651 | — |
| Research Site 10001-111 | Myrtle Beach | South Carolina | 29588 | — |
| Research Site 10001-133 | Pelzer | South Carolina | 29669 | — |
| Research Site 10001-026 | Spartanburg | South Carolina | 29303 | — |
| Research Site 10001-103 | Rapid City | South Dakota | 57701 | — |
| Research Site 10001-146 | Athens | Tennessee | 37303 | — |
| Research Site 10001-130 | Kingsport | Tennessee | 37660 | — |
| Research Site 10001-118 | Knoxville | Tennessee | 37909 | — |
| Research Site 10001-100 | Amarillo | Texas | 79106 | — |
| Research Site 10001-087 | Austin | Texas | 78726 | — |
| Research Site 10001-117 | Austin | Texas | 78756 | — |
| Research Site 10001-009 | Dallas | Texas | 75234 | — |
| Research Site 10001-068 | Edinburg | Texas | 78503 | — |
| Research Site 10001-126 | Fort Worth | Texas | 76106 | — |
| Research Site 10001-031 | Houston | Texas | 77002 | — |
| Research Site 10001-088 | Houston | Texas | 77024 | — |
| Research Site 10001-091 | Houston | Texas | 77027 | — |
| Research Site 10001-061 | Houston | Texas | 77058 | — |
| Research Site 10001-032 | Houston | Texas | 77070 | — |
| Research Site 10001-025 | Lubbock | Texas | 79410 | — |
| Research Site 10001-057 | New Braunfels | Texas | 78130 | — |
| Research Site 10001-106 | Powell | Texas | 37849 | — |
| Research Site 10001-079 | Round Rock | Texas | 78681 | — |
| Research Site 10001-071 | San Antonio | Texas | 78229 | — |
| Research Site 10001-083 | Schertz | Texas | 78154 | — |
| Research Site 10001-149 | Shavano Park | Texas | 78231 | — |
| Research Site 10001-045 | Tomball | Texas | 77375 | — |
| Research Site 10001-005 | Layton | Utah | 84041 | — |
| Research Site 10001-002 | Salt Lake City | Utah | 84123 | — |
| Research Site 10001-052 | Salt Lake City | Utah | 94107 | — |
| Research Site 10001-093 | Falls Church | Virginia | 22042 | — |
| Research Site 10001-085 | Manassas | Virginia | 20110 | — |
| Research Site 10001-094 | Midlothian | Virginia | 23114 | — |
| Research Site 10001-023 | Richmond | Virginia | 23294 | — |
| Research Site 10001-029 | Suffolk | Virginia | 23435 | — |
| Research Site 10001-114 | Tacoma | Washington | 98405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03399370, 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 5, 2020 · Synced Oct 22, 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 NCT03399370 live on ClinicalTrials.gov.