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Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol (ORION-10)

Primary Purpose

ASCVD, Elevated Cholesterol

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Inclisiran Sodium
Placebo
Sponsored by
The Medicines Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ASCVD focused on measuring Inclisiran sodium, ASCVD, LDL-C

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Research Site 10001-015
  • Research Site 10001-138
  • Research Site 10001-113
  • Research Site 10001-058
  • Research Site 10001-037
  • Research Site 10001-076
  • Research Site 10001-013
  • Research Site 10001-077
  • Research Site 10001-136
  • Research Site 10001-051
  • Research Site 10001-019
  • Research Site 10001-004
  • Research Site 10001-132
  • Research Site 10001-073
  • Research Site 10001-050
  • Research Site 10001-011
  • Research Site 10001-065
  • Research Site 10001-150
  • Research Site 10001-043
  • Research Site 10001-022
  • Research Site 10001-033
  • Research Site 10001-105
  • Research Site 10001-008
  • Research Site 10001-153
  • Research Site 10001-044
  • Research Site 10001-047
  • Research Site 10001-084
  • Research Site 10001-155
  • Research Site 10001-099
  • Research Site 10001-127
  • Research Site 10001-119
  • Research Site 10001-070
  • Research Site 10001-067
  • Research Site 10001-139
  • Research Site 10001-039
  • Research Site 10001-098
  • Research Site 10001-080
  • Research Site 10001-081
  • Research Site 10001-140
  • Research Site 10001-142
  • Research Site 10001-030
  • Research Site 10001-089
  • Research Site 10001-116
  • Research Site 10001-027
  • Research Site 10001-115
  • Research Site 10001-048
  • Research Site 10001-147
  • Research Site 10001-003
  • Research Site 10001-104
  • Research Site 10001-090
  • Research Site 10001-102
  • Research Site 10001-123
  • Research Site 10001-038
  • Research Site 10001-143
  • Research Site 10001-069
  • Research Site 10001-137
  • Research Site 10001-092
  • Research Site 10001-059
  • Research Site 10001-158
  • Research Site 10001-035
  • Research Site 10001-036
  • Research Site 10001-082
  • Research Site 1001-020
  • Research Site 10001-040
  • Research Site 10001-074
  • Research Site 10001-028
  • Research Site 10001-125
  • Research Site 10001-108
  • Research Site 10001-107
  • Research Site 10001-144
  • Research Site 10001-041
  • Research Site 10001-101
  • Research Site 10001-024
  • Research Site 10001-095
  • Research Site 10001-078
  • Research Site 10001-034
  • Research Site 10001-018
  • Research Site 10001-056
  • Research Site 10001-156
  • Research Site 10001-007
  • Research Site 10001-053
  • Research Site 10001-021
  • Research Site 10001-112
  • Research Site 10001-124
  • Research Site 10001-060
  • Research Site 10001-055
  • Research Site 10001-054
  • Research Site 10001-122
  • Research Site 10001-128
  • Research Site 10001-042
  • Research Site 10001-129
  • Research Site 10001-110
  • Research Site 10001-063
  • Research Site 10001-064
  • Research Site 10001-145
  • Research Site 10001-046
  • Research Site 10001-016
  • Research Site 10001-120
  • Research Site 10001-154
  • Research Site 10001-010
  • Research Site 10001-134
  • Research Site 10001-014
  • Research Site 10001-012
  • Research Site 10001-141
  • Research Site 10001-148
  • Research Site 10001-017
  • Research Site 10001-109
  • Research Site 10001-001
  • Research Site 10001-006
  • Research Site 10001-075.
  • Research Site 10001-111
  • Research Site 10001-133
  • Research Site 10001-026
  • Research Site 10001-103
  • Research Site 10001-146
  • Research Site 10001-130
  • Research Site 10001-118
  • Research Site 10001-100
  • Research Site 10001-087
  • Research Site 10001-117
  • Research Site 10001-009
  • Research Site 10001-068
  • Research Site 10001-126
  • Research Site 10001-031
  • Research Site 10001-088
  • Research Site 10001-091
  • Research Site 10001-061
  • Research Site 10001-032
  • Research Site 10001-025
  • Research Site 10001-057
  • Research Site 10001-106
  • Research Site 10001-079
  • Research Site 10001-071
  • Research Site 10001-083
  • Research Site 10001-149
  • Research Site 10001-045
  • Research Site 10001-005
  • Research Site 10001-002
  • Research Site 10001-052
  • Research Site 10001-093
  • Research Site 10001-085
  • Research Site 10001-094
  • Research Site 10001-023
  • Research Site 10001-029
  • Research Site 10001-114

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Inclisiran

Saline Solution

Arm Description

Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection on Day 1, Day 90, then every 6 months.

Placebo will be administered as a SC injection of saline solution on Day 1, Day 90, then every 6 months.

Outcomes

Primary Outcome Measures

Percentage Change in LDL-C From Baseline to Day 510
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

Secondary Outcome Measures

Absolute Change in LDL-C From Baseline to Day 510
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
Percentage Change in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) From Baseline to Day 510
Percentage Change in Total Cholesterol From Baseline to Day 510
Percentage Change in Apolipoprotein B (ApoB) From Baseline to Day 510
Percentage Change in Non-HDL-C From Baseline to Day 510

Full Information

First Posted
January 3, 2018
Last Updated
September 8, 2020
Sponsor
The Medicines Company
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1. Study Identification

Unique Protocol Identification Number
NCT03399370
Brief Title
Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol
Acronym
ORION-10
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
December 21, 2017 (Actual)
Primary Completion Date
September 10, 2019 (Actual)
Study Completion Date
September 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Medicines Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ASCVD, Elevated Cholesterol
Keywords
Inclisiran sodium, ASCVD, LDL-C

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
1561 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inclisiran
Arm Type
Experimental
Arm Description
Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection on Day 1, Day 90, then every 6 months.
Arm Title
Saline Solution
Arm Type
Placebo Comparator
Arm Description
Placebo will be administered as a SC injection of saline solution on Day 1, Day 90, then every 6 months.
Intervention Type
Drug
Intervention Name(s)
Inclisiran Sodium
Intervention Description
Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Saline Solution
Intervention Description
Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection).
Primary Outcome Measure Information:
Title
Percentage Change in LDL-C From Baseline to Day 510
Time Frame
Baseline, Day 510
Title
Time-adjusted Percentage Change in LDL-C Levels From Baseline After Day 90 and up to Day 540
Description
Assessments performed at Baseline, Day 90, Day 540, time-adjusted percent change at Day 540 reported
Time Frame
Baseline, Day 90 to Day 540
Secondary Outcome Measure Information:
Title
Absolute Change in LDL-C From Baseline to Day 510
Time Frame
Baseline, Day 510
Title
Time-adjusted Absolute Change in LDL-C From Baseline After Day 90 and up to Day 540
Description
Assessments performed at Baseline, Day 90, Day 540, time-adjusted percent change at Day 540 reported
Time Frame
Baseline, Day 90 to Day 540
Title
Percentage Change in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) From Baseline to Day 510
Time Frame
Baseline, Day 510
Title
Percentage Change in Total Cholesterol From Baseline to Day 510
Time Frame
Baseline, Day 510
Title
Percentage Change in Apolipoprotein B (ApoB) From Baseline to Day 510
Time Frame
Baseline, Day 510
Title
Percentage Change in Non-HDL-C From Baseline to Day 510
Time Frame
Baseline, Day 510

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female participants ≥18 years of age. History of ASCVD (coronary heart disease [CHD], cardiovascular disease [CVD], or peripheral arterial disease [PAD]). Serum LDL-C ≥1.8 millimole (mmol)/liter (L) (≥70 mg/dL). Fasting triglyceride <4.52 mmol/L (<400 mg/dL) at screening. Participants on statins should be receiving a maximally tolerated dose. Participants not receiving statins must have documented evidence of intolerance to all doses of at least 2 different statins. 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: New York Heart Association (NYHA) class IV heart failure. Uncontrolled cardiac arrhythmia Uncontrolled severe hypertension Active liver disease 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: Women >2 years postmenopausal (defined as 1 year or longer since last menstrual period) and more than 55 years of age. Postmenopausal women (as defined above) and less than 55 years of age with a negative pregnancy test within 24 hours of randomization. Women who are surgically sterilized at least 3 months prior to enrollment. Males who are unwilling to use an acceptable method of birth control during the entire study period (such as condom with spermicide). Treatment with other investigational products or devices within 30 days or 5 half-lives of the screening visit, whichever is longer. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Wright, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site 10001-015
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
Country
United States
Facility Name
Research Site 10001-138
City
Foley
State/Province
Alabama
ZIP/Postal Code
36535
Country
United States
Facility Name
Research Site 10001-113
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Research Site 10001-058
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Research Site 10001-037
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36117
Country
United States
Facility Name
Research Site 10001-076
City
Saraland
State/Province
Alabama
ZIP/Postal Code
36571
Country
United States
Facility Name
Research Site 10001-013
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Research Site 10001-077
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85213
Country
United States
Facility Name
Research Site 10001-136
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
Facility Name
Research Site 10001-051
City
Surprise
State/Province
Arizona
ZIP/Postal Code
85374
Country
United States
Facility Name
Research Site 10001-019
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Research Site 10001-004
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Research Site 10001-132
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85745
Country
United States
Facility Name
Research Site 10001-073
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Research Site 10001-050
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
Facility Name
Research Site 10001-011
City
Carlsbad
State/Province
California
ZIP/Postal Code
92008
Country
United States
Facility Name
Research Site 10001-065
City
El Cajon
State/Province
California
ZIP/Postal Code
92020
Country
United States
Facility Name
Research Site 10001-150
City
Los Angeles
State/Province
California
ZIP/Postal Code
90022
Country
United States
Facility Name
Research Site 10001-043
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
Research Site 10001-022
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
Research Site 10001-033
City
Sacramento
State/Province
California
ZIP/Postal Code
95821-2134
Country
United States
Facility Name
Research Site 10001-105
City
San Ramon
State/Province
California
ZIP/Postal Code
94582
Country
United States
Facility Name
Research Site 10001-008
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95405
Country
United States
Facility Name
Research Site 10001-153
City
Spring Valley
State/Province
California
ZIP/Postal Code
91978
Country
United States
Facility Name
Research Site 10001-044
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Research Site 10001-047
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33434
Country
United States
Facility Name
Research Site 10001-084
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Research Site 10001-155
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Research Site 10001-099
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
Research Site 10001-127
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Facility Name
Research Site 10001-119
City
Fleming Island
State/Province
Florida
ZIP/Postal Code
32003
Country
United States
Facility Name
Research Site 10001-070
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Research Site 10001-067
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Research Site 10001-139
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Research Site 10001-039
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Research Site 10001-098
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Research Site 10001-080
City
Miami Springs
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Research Site 10001-081
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Research Site 10001-140
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Research Site 10001-142
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Research Site 10001-030
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Research Site 10001-089
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Research Site 10001-116
City
Miami
State/Province
Florida
ZIP/Postal Code
33183
Country
United States
Facility Name
Research Site 10001-027
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Research Site 10001-115
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
Facility Name
Research Site 10001-048
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33029
Country
United States
Facility Name
Research Site 10001-147
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33029
Country
United States
Facility Name
Research Site 10001-003
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Research Site 10001-104
City
Ponte Vedra
State/Province
Florida
ZIP/Postal Code
32081
Country
United States
Facility Name
Research Site 10001-090
City
Saint Augustine
State/Province
Florida
ZIP/Postal Code
32086
Country
United States
Facility Name
Research Site 10001-102
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33713
Country
United States
Facility Name
Research Site 10001-123
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239-3513
Country
United States
Facility Name
Research Site 10001-038
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Research Site 10001-143
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Research Site 10001-069
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Research Site 10001-137
City
Dunwoody
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
Facility Name
Research Site 10001-092
City
Macon
State/Province
Georgia
ZIP/Postal Code
31210
Country
United States
Facility Name
Research Site 10001-059
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
Research Site 10001-158
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60602
Country
United States
Facility Name
Research Site 10001-035
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
Facility Name
Research Site 10001-036
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Research Site 10001-082
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Research Site 1001-020
City
Sellersburg
State/Province
Indiana
ZIP/Postal Code
47172
Country
United States
Facility Name
Research Site 10001-040
City
Valparaiso
State/Province
Indiana
ZIP/Postal Code
46383
Country
United States
Facility Name
Research Site 10001-074
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Research Site 10001-028
City
Hutchinson
State/Province
Kansas
ZIP/Postal Code
67502
Country
United States
Facility Name
Research Site 10001-125
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Research Site 10001-108
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
Research Site 10001-107
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303
Country
United States
Facility Name
Research Site 10001-144
City
Crowley
State/Province
Louisiana
ZIP/Postal Code
70526
Country
United States
Facility Name
Research Site 10001-041
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
Research Site 10001-101
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
Country
United States
Facility Name
Research Site 10001-024
City
Flint
State/Province
Michigan
ZIP/Postal Code
48504
Country
United States
Facility Name
Research Site 10001-095
City
Grandville
State/Province
Michigan
ZIP/Postal Code
49418
Country
United States
Facility Name
Research Site 10001-078
City
Sterling Heights
State/Province
Michigan
ZIP/Postal Code
48310
Country
United States
Facility Name
Research Site 10001-034
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Research Site 10001-018
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Research Site 10001-056
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Research Site 10001-156
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63136
Country
United States
Facility Name
Research Site 10001-007
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Research Site 10001-053
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Research Site 10001-021
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Research Site 10001-112
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Research Site 10001-124
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89121
Country
United States
Facility Name
Research Site 10001-060
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
Facility Name
Research Site 10001-055
City
Raritan
State/Province
New Jersey
ZIP/Postal Code
08869
Country
United States
Facility Name
Research Site 10001-054
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
Research Site 10001-122
City
Binghamton
State/Province
New York
ZIP/Postal Code
13901
Country
United States
Facility Name
Research Site 10001-128
City
Endwell
State/Province
New York
ZIP/Postal Code
13760
Country
United States
Facility Name
Research Site 10001-042
City
New Windsor
State/Province
New York
ZIP/Postal Code
12553
Country
United States
Facility Name
Research Site 10001-129
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
Research Site 10001-110
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Research Site 10001-063
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
Facility Name
Research Site 10001-064
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
Research Site 10001-145
City
Mooresville
State/Province
North Carolina
ZIP/Postal Code
28117
Country
United States
Facility Name
Research Site 10001-046
City
Shelby
State/Province
North Carolina
ZIP/Postal Code
28150
Country
United States
Facility Name
Research Site 10001-016
City
Akron
State/Province
Ohio
ZIP/Postal Code
443311
Country
United States
Facility Name
Research Site 10001-120
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Research Site 10001-154
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
Facility Name
Research Site 10001-010
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Research Site 10001-134
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45246
Country
United States
Facility Name
Research Site 10001-014
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Research Site 10001-012
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Research Site 10001-141
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45419
Country
United States
Facility Name
Research Site 10001-148
City
Marion
State/Province
Ohio
ZIP/Postal Code
43302
Country
United States
Facility Name
Research Site 10001-017
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73003
Country
United States
Facility Name
Research Site 10001-109
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Research Site 10001-001
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Research Site 10001-006
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Research Site 10001-075.
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Research Site 10001-111
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29588
Country
United States
Facility Name
Research Site 10001-133
City
Pelzer
State/Province
South Carolina
ZIP/Postal Code
29669
Country
United States
Facility Name
Research Site 10001-026
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Research Site 10001-103
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Research Site 10001-146
City
Athens
State/Province
Tennessee
ZIP/Postal Code
37303
Country
United States
Facility Name
Research Site 10001-130
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Research Site 10001-118
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Research Site 10001-100
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Research Site 10001-087
City
Austin
State/Province
Texas
ZIP/Postal Code
78726
Country
United States
Facility Name
Research Site 10001-117
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Research Site 10001-009
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
Research Site 10001-068
City
Edinburg
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Research Site 10001-126
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76106
Country
United States
Facility Name
Research Site 10001-031
City
Houston
State/Province
Texas
ZIP/Postal Code
77002
Country
United States
Facility Name
Research Site 10001-088
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Research Site 10001-091
City
Houston
State/Province
Texas
ZIP/Postal Code
77027
Country
United States
Facility Name
Research Site 10001-061
City
Houston
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
Facility Name
Research Site 10001-032
City
Houston
State/Province
Texas
ZIP/Postal Code
77070
Country
United States
Facility Name
Research Site 10001-025
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
Research Site 10001-057
City
New Braunfels
State/Province
Texas
ZIP/Postal Code
78130
Country
United States
Facility Name
Research Site 10001-106
City
Powell
State/Province
Texas
ZIP/Postal Code
37849
Country
United States
Facility Name
Research Site 10001-079
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Research Site 10001-071
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Research Site 10001-083
City
Schertz
State/Province
Texas
ZIP/Postal Code
78154
Country
United States
Facility Name
Research Site 10001-149
City
Shavano Park
State/Province
Texas
ZIP/Postal Code
78231
Country
United States
Facility Name
Research Site 10001-045
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
Research Site 10001-005
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
Research Site 10001-002
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84123
Country
United States
Facility Name
Research Site 10001-052
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
94107
Country
United States
Facility Name
Research Site 10001-093
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Research Site 10001-085
City
Manassas
State/Province
Virginia
ZIP/Postal Code
20110
Country
United States
Facility Name
Research Site 10001-094
City
Midlothian
State/Province
Virginia
ZIP/Postal Code
23114
Country
United States
Facility Name
Research Site 10001-023
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
Research Site 10001-029
City
Suffolk
State/Province
Virginia
ZIP/Postal Code
23435
Country
United States
Facility Name
Research Site 10001-114
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32187462
Citation
Ray KK, Wright RS, Kallend D, Koenig W, Leiter LA, Raal FJ, Bisch JA, Richardson T, Jaros M, Wijngaard PLJ, Kastelein JJP; ORION-10 and ORION-11 Investigators. Two Phase 3 Trials of Inclisiran in Patients with Elevated LDL Cholesterol. N Engl J Med. 2020 Apr 16;382(16):1507-1519. doi: 10.1056/NEJMoa1912387. Epub 2020 Mar 18.
Results Reference
derived

Learn more about this trial

Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol

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