ASCVD Clinical Trial
— ORION-10Official 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)
| Verified date | September 2020 |
| Source | The Medicines Company |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 1561 |
| Est. completion date | September 17, 2019 |
| Est. primary completion date | September 10, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: 1. Male or female participants =18 years of age. 2. History of ASCVD (coronary heart disease [CHD], cardiovascular disease [CVD], or peripheral arterial disease [PAD]). 3. Serum LDL-C =1.8 millimole (mmol)/liter (L) (=70 mg/dL). 4. Fasting triglyceride <4.52 mmol/L (<400 mg/dL) at screening. 5. Participants on statins should be receiving a maximally tolerated dose. 6. Participants not receiving statins must have documented evidence of intolerance to all doses of at least 2 different statins. 7. Subjects on lipid-lower therapies (such as a statin and/or ezetimibe) should be on a stable dose for =30 days before screening with no planned medication or dose change during study participation. Exclusion Criteria: 1. New York Heart Association (NYHA) class IV heart failure. 2. Uncontrolled cardiac arrhythmia 3. Uncontrolled severe hypertension 4. Active liver disease 5. Females who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least 2 methods of highly effective contraception (failure rate less than 1% per year) (for example, combined oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, or intrauterine device) for the entire duration of the study. Exemptions from this criterion: 1. Women >2 years postmenopausal (defined as 1 year or longer since last menstrual period) and more than 55 years of age. 2. Postmenopausal women (as defined above) and less than 55 years of age with a negative pregnancy test within 24 hours of randomization. 3. Women who are surgically sterilized at least 3 months prior to enrollment. 6. Males who are unwilling to use an acceptable method of birth control during the entire study period (such as condom with spermicide). 7. Treatment with other investigational products or devices within 30 days or 5 half-lives of the screening visit, whichever is longer. 8. Treatment (within 90 days of screening) with monoclonal antibodies directed towards PCSK9 The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Research Site 10001-016 | Akron | Ohio |
| United States | Research Site 10001-054 | Albany | New York |
| United States | Research Site 10001-100 | Amarillo | Texas |
| United States | Research Site 10001-001 | Anderson | South Carolina |
| United States | Research Site 10001-059 | Arlington Heights | Illinois |
| United States | Research Site 10001-146 | Athens | Tennessee |
| United States | Research Site 10001-069 | Atlanta | Georgia |
| United States | Research Site 10001-087 | Austin | Texas |
| United States | Research Site 10001-117 | Austin | Texas |
| United States | Research Site 10001-073 | Beverly Hills | California |
| United States | Research Site 10001-122 | Binghamton | New York |
| United States | Research Site 10001-015 | Birmingham | Alabama |
| United States | Research Site 10001-047 | Boca Raton | Florida |
| United States | Research Site 10001-060 | Bridgewater | New Jersey |
| United States | Research Site 10001-050 | Canoga Park | California |
| United States | Research Site 10001-011 | Carlsbad | California |
| United States | Research Site 10001-063 | Cary | North Carolina |
| United States | Research Site 10001-013 | Chandler | Arizona |
| United States | Research Site 10001-035 | Chicago | Illinois |
| United States | Research Site 10001-158 | Chicago | Illinois |
| United States | Research Site 10001-010 | Cincinnati | Ohio |
| United States | Research Site 10001-120 | Cincinnati | Ohio |
| United States | Research Site 10001-134 | Cincinnati | Ohio |
| United States | Research Site 10001-154 | Cincinnati | Ohio |
| United States | Research Site 10001-084 | Clearwater | Florida |
| United States | Research Site 10001-099 | Clearwater | Florida |
| United States | Research Site 10001-155 | Clearwater | Florida |
| United States | Research Site 10001-012 | Columbus | Ohio |
| United States | Research Site 10001-014 | Columbus | Ohio |
| United States | Research Site 10001-144 | Crowley | Louisiana |
| United States | Research Site 10001-009 | Dallas | Texas |
| United States | Research Site 10001-141 | Dayton | Ohio |
| United States | Research Site 10001-127 | Daytona Beach | Florida |
| United States | Research Site 10001-137 | Dunwoody | Georgia |
| United States | Research Site 10001-018 | Edina | Minnesota |
| United States | Research Site 10001-068 | Edinburg | Texas |
| United States | Research Site 10001-017 | Edmond | Oklahoma |
| United States | Research Site 10001-065 | El Cajon | California |
| United States | Research Site 10001-128 | Endwell | New York |
| United States | Research Site 10001-036 | Evanston | Illinois |
| United States | Research Site 10001-093 | Falls Church | Virginia |
| United States | Research Site 10001-119 | Fleming Island | Florida |
| United States | Research Site 10001-024 | Flint | Michigan |
| United States | Research Site 10001-138 | Foley | Alabama |
| United States | Research Site 10001-070 | Fort Lauderdale | Florida |
| United States | Research Site 10001-126 | Fort Worth | Texas |
| United States | Research Site 10001-095 | Grandville | Michigan |
| United States | Research Site 10001-064 | Greensboro | North Carolina |
| United States | Research Site 10001-006 | Greer | South Carolina |
| United States | Research Site 10001-075. | Greer | South Carolina |
| United States | Research Site 10001-067 | Hialeah | Florida |
| United States | Research Site 10001-031 | Houston | Texas |
| United States | Research Site 10001-032 | Houston | Texas |
| United States | Research Site 10001-061 | Houston | Texas |
| United States | Research Site 10001-088 | Houston | Texas |
| United States | Research Site 10001-091 | Houston | Texas |
| United States | Research Site 10001-113 | Huntsville | Alabama |
| United States | Research Site 10001-028 | Hutchinson | Kansas |
| United States | Research Site 10001-082 | Indianapolis | Indiana |
| United States | Research Site 10001-039 | Jacksonville | Florida |
| United States | Research Site 10001-098 | Jacksonville | Florida |
| United States | Research Site 10001-139 | Jacksonville | Florida |
| United States | Research Site 10001-130 | Kingsport | Tennessee |
| United States | Research Site 10001-118 | Knoxville | Tennessee |
| United States | Research Site 10001-041 | Lake Charles | Louisiana |
| United States | Research Site 10001-112 | Las Vegas | Nevada |
| United States | Research Site 10001-124 | Las Vegas | Nevada |
| United States | Research Site 10001-005 | Layton | Utah |
| United States | Research Site 10001-108 | Lexington | Kentucky |
| United States | Research Site 10001-125 | Lexington | Kentucky |
| United States | Research Site 10001-150 | Los Angeles | California |
| United States | Research Site 10001-025 | Lubbock | Texas |
| United States | Research Site 10001-092 | Macon | Georgia |
| United States | Research Site 10001-085 | Manassas | Virginia |
| United States | Research Site 10001-148 | Marion | Ohio |
| United States | Research Site 10001-077 | Mesa | Arizona |
| United States | Research Site 10001-030 | Miami | Florida |
| United States | Research Site 10001-081 | Miami | Florida |
| United States | Research Site 10001-089 | Miami | Florida |
| United States | Research Site 10001-116 | Miami | Florida |
| United States | Research Site 10001-140 | Miami | Florida |
| United States | Research Site 10001-142 | Miami | Florida |
| United States | Research Site 10001-080 | Miami Springs | Florida |
| United States | Research Site 10001-094 | Midlothian | Virginia |
| United States | Research Site 10001-058 | Mobile | Alabama |
| United States | Research Site 10001-101 | Monroe | Louisiana |
| United States | Research Site 10001-037 | Montgomery | Alabama |
| United States | Research Site 10001-145 | Mooresville | North Carolina |
| United States | Research Site 10001-111 | Myrtle Beach | South Carolina |
| United States | Research Site 10001-057 | New Braunfels | Texas |
| United States | Research Site 10001-042 | New Windsor | New York |
| United States | Research Site 10001-022 | Northridge | California |
| United States | Research Site 10001-043 | Northridge | California |
| United States | Research Site 10001-021 | Omaha | Nebraska |
| United States | Research Site 10001-053 | Omaha | Nebraska |
| United States | Research Site 10001-107 | Owensboro | Kentucky |
| United States | Research Site 10001-133 | Pelzer | South Carolina |
| United States | Research Site 10001-027 | Pembroke Pines | Florida |
| United States | Research Site 10001-048 | Pembroke Pines | Florida |
| United States | Research Site 10001-115 | Pembroke Pines | Florida |
| United States | Research Site 10001-147 | Pembroke Pines | Florida |
| United States | Research Site 10001-136 | Phoenix | Arizona |
| United States | Research Site 10001-003 | Pinellas Park | Florida |
| United States | Research Site 10001-104 | Ponte Vedra | Florida |
| United States | Research Site 10001-129 | Poughkeepsie | New York |
| United States | Research Site 10001-106 | Powell | Texas |
| United States | Research Site 10001-103 | Rapid City | South Dakota |
| United States | Research Site 10001-055 | Raritan | New Jersey |
| United States | Research Site 10001-023 | Richmond | Virginia |
| United States | Research Site 10001-079 | Round Rock | Texas |
| United States | Research Site 10001-033 | Sacramento | California |
| United States | Research Site 10001-090 | Saint Augustine | Florida |
| United States | Research Site 10001-007 | Saint Louis | Missouri |
| United States | Research Site 10001-156 | Saint Louis | Missouri |
| United States | Research Site 10001-056 | Saint Paul | Minnesota |
| United States | Research Site 10001-102 | Saint Petersburg | Florida |
| United States | Research Site 10001-002 | Salt Lake City | Utah |
| United States | Research Site 10001-052 | Salt Lake City | Utah |
| United States | Research Site 10001-071 | San Antonio | Texas |
| United States | Research Site 10001-105 | San Ramon | California |
| United States | Research Site 10001-008 | Santa Rosa | California |
| United States | Research Site 10001-076 | Saraland | Alabama |
| United States | Research Site 10001-123 | Sarasota | Florida |
| United States | Research Site 10001-083 | Schertz | Texas |
| United States | Research Site 1001-020 | Sellersburg | Indiana |
| United States | Research Site 10001-149 | Shavano Park | Texas |
| United States | Research Site 10001-046 | Shelby | North Carolina |
| United States | Research Site 10001-026 | Spartanburg | South Carolina |
| United States | Research Site 10001-153 | Spring Valley | California |
| United States | Research Site 10001-078 | Sterling Heights | Michigan |
| United States | Research Site 10001-029 | Suffolk | Virginia |
| United States | Research Site 10001-051 | Surprise | Arizona |
| United States | Research Site 10001-114 | Tacoma | Washington |
| United States | Research Site 10001-038 | Tampa | Florida |
| United States | Research Site 10001-143 | Tampa | Florida |
| United States | Research Site 10001-045 | Tomball | Texas |
| United States | Research Site 10001-044 | Torrance | California |
| United States | Research Site 10001-034 | Troy | Michigan |
| United States | Research Site 10001-004 | Tucson | Arizona |
| United States | Research Site 10001-019 | Tucson | Arizona |
| United States | Research Site 10001-132 | Tucson | Arizona |
| United States | Research Site 10001-040 | Valparaiso | Indiana |
| United States | Research Site 10001-074 | West Des Moines | Iowa |
| United States | Research Site 10001-110 | Williamsville | New York |
| United States | Research Site 10001-109 | Wyomissing | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| The Medicines Company |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage Change in LDL-C From Baseline to Day 510 | Baseline, Day 510 | ||
| Primary | Time-adjusted Percentage Change in LDL-C Levels From Baseline After Day 90 and up to Day 540 | Assessments performed at Baseline, Day 90, Day 540, time-adjusted percent change at Day 540 reported | Baseline, Day 90 to Day 540 | |
| Secondary | Absolute Change in LDL-C From Baseline to Day 510 | Baseline, Day 510 | ||
| Secondary | Time-adjusted Absolute Change in LDL-C From Baseline After Day 90 and up to Day 540 | Assessments performed at Baseline, Day 90, Day 540, time-adjusted percent change at Day 540 reported | Baseline, Day 90 to Day 540 | |
| Secondary | Percentage Change in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) From Baseline to Day 510 | Baseline, Day 510 | ||
| Secondary | Percentage Change in Total Cholesterol From Baseline to Day 510 | Baseline, Day 510 | ||
| Secondary | Percentage Change in Apolipoprotein B (ApoB) From Baseline to Day 510 | Baseline, Day 510 | ||
| Secondary | Percentage Change in Non-HDL-C From Baseline to Day 510 | Baseline, Day 510 |
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