Phase
Condition
High Cholesterol (Hyperlipidemia)
Hypercholesterolemia
Familial Hypercholesterolemia
Treatment
Inclisiran Sodium
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Completion on a previously qualifying inclisiran Phase II trial MDCO-PCS-16-01 (ORION-3), or Phase III lipid lowering ORION feeder study [MDCO-PCS-17-03 (ORION-9),MDCO-PCS-17-4 (ORION-10), or MDCO-PCS-17-08 (ORION-11)] meaning the subject receivedthe last dose of study drug and completed the final study visit per applicableprotocol.
- On current lipid-lowering therapies (such as a statin and/or ezetimibe) from previousstudy with no planned medication or dose change during study participation.
- Willing and able to give informed consent before initiation of any study-relatedprocedures and willing to comply with all required study procedures.
Exclusion
Exclusion Criteria:
- Any uncontrolled or serious disease, or any medical or surgical condition, that mayeither interfere with participation in the clinical study, and/or put the subject atsignificant risk [according to investigator's (or delegate's) judgment] if he/sheparticipates in the clinical study.
- An underlying known disease, or surgical, physical, or medical condition that, in theopinion of the investigator (or delegate) might interfere with interpretation of theclinical study results.
- Severe concomitant noncardiovascular disease that carries the risk of reducing lifeexpectancy to less than 3 years,
- Active liver disease defined as any known current infectious, neoplastic, or metabolicpathology of the liver or unexplained alanine aminotransferase (ALT), aspartateaminotransferase (AST), elevation >3x the upper limit of normal (ULN), or totalbilirubin (TBIL) elevation >2x ULN at the last recorded visit in the feeder studyprior to study entry visit.
- Females who are pregnant or nursing, or who are of childbearing potential andunwilling to use at least one method of acceptable effective contraception (eg, oralcontraceptives, barrier methods, approved contraceptive implant, long-term injectablecontraception, intrauterine device) for the entire duration of the study. Exemptionsfrom this criterion:
- Women >2 years postmenopausal (defined as 1 year or longer since last menstrualperiod) and more than 55 years of age.
- Postmenopausal women (as defined above) and less than 55 years of age with anegative pregnancy test within 24 hours of randomization.
- Women who are surgically sterilized at least 3 months prior to enrollment.
- Planned use of other investigational medicinal products other than inclisiran ordevices during the course of the study.
- Any condition that according to the investigator could interfere with the conduct ofthe study, such as but not limited to:
- Subjects who are unable to communicate or to cooperate with the investigator
- Unable to understand the protocol requirements, instructions and study-relatedrestrictions, the nature, scope, and possible consequences of the study (including subjects whose cooperation is doubtful due to drug abuse or alcoholdependency)
- Unlikely to comply with the protocol requirements, instructions, andstudy-related restrictions (eg, uncooperative attitude, inability to return forfollow-up visits, and improbability of completing the study)
- Have any medical or surgical condition, which in the opinion of the investigatorwould put the subject at increased risk from participating in the study
- Persons directly involved in the conduct of the study. The above information is not intended to contain all considerations relevant to aparticipant's potential participation in a clinical trial.
Study Design
Study Description
Connect with a study center
Research Site 90011-005
Chicoutimi, Quebec G7H 7K9
CanadaSite Not Available
Research Site 90011-001
Montréal, Quebec H2W 1R7
CanadaSite Not Available
Research Site 90011-002
Québec, Quebec GIV 4W2
CanadaSite Not Available
Research Site 11420-002
Chomutov, 430 02
CzechiaSite Not Available
Research Site 90420-001
Praha, 140 21
CzechiaSite Not Available
Research Site 90420-006
Praha, 180 81
CzechiaSite Not Available
Research Site 11420-003
Uherské Hradiště, 686 01
CzechiaSite Not Available
Research Site 90045-001
Aalborg, Nordjylland 9000
DenmarkSite Not Available
Research Site 90045-004
Esbjerg, 6700
DenmarkSite Not Available
Research Site 90045-003
Herning, 7400
DenmarkSite Not Available
Research Site 90045-006
Hvidovre, 2650
DenmarkSite Not Available
Research Site 90045-002
Roskilde, 4000
DenmarkSite Not Available
Research Site 90045-005
Viborg, 8800
DenmarkSite Not Available
Research Site 11049-006
Berlin, 12627
GermanySite Not Available
Research Site 11049-002
Bochum, 47787
GermanySite Not Available
Research Site 11049-003
Frankfurt, 60313
GermanySite Not Available
Research Site 11049-001
Heidelberg, 69120
GermanySite Not Available
Research Site 11049-007
Heidelberg, 69120
GermanySite Not Available
Research Site 11036-001
Budapest,
HungarySite Not Available
Research Site 11036-004
Debrecen,
HungarySite Not Available
Research Site 11036-002
Hatvan,
HungarySite Not Available
Research Site 11036-003
Zalaegerszeg,
HungarySite Not Available
Research Site 90031-001
Amersfoort, 3813 TZ
NetherlandsSite Not Available
Research Site 90031-003
Amsterdam, 1105 AZ
NetherlandsSite Not Available
Research Site 90031-006
Goes, 4462 RA
NetherlandsSite Not Available
Research Site 90031-009
Hoorn, 1624 NP
NetherlandsSite Not Available
Research Site 90031-005
Utrecht,
NetherlandsSite Not Available
Research SIte 11048-016
Brzozowie,
PolandSite Not Available
Research Site 11048-011
Bydgoszcz,
PolandSite Not Available
Research Site 11048-018
Bydgoszcz, 85-079
PolandSite Not Available
Research Site 11048-004
Gdańsk,
PolandSite Not Available
Research Site 11048-005
Gdynia,
PolandSite Not Available
Research SIte 11048-012
Katowice,
PolandSite Not Available
Research Site 11048-007
Katowice,
PolandSite Not Available
Research SIte 11048-014
Kraków,
PolandSite Not Available
Research Site 11048-003
Kraków,
PolandSite Not Available
Research Site 11048-008
Lublin,
PolandSite Not Available
Research Site 11048-001
Poznań,
PolandSite Not Available
Research Site 11048-019
Ruda Śląska, 41-709
PolandSite Not Available
Research SIte 11048-013
Rzeszów,
PolandSite Not Available
Research SIte 11048-015
Tarnów,
PolandSite Not Available
Research Site 11048-006
Warsaw,
PolandSite Not Available
Research Site 11048-009
Warsaw,
PolandSite Not Available
Research Site 11048-002
Wrocław,
PolandSite Not Available
Research Site 11048-010
Wrocław,
PolandSite Not Available
Research Site 90027-008
Bellville, Cape Town 7530
South AfricaSite Not Available
Research Site 90027-007
Lyttelton, Cape Town 0157
South AfricaSite Not Available
Research Site 90027-003
Bloemfontein, Free State 9301
South AfricaSite Not Available
Research Site 90027-010
Johannesburg, Gauteng 2193
South AfricaSite Not Available
Research Site 11027-005
Kempton Park, Gauteng 1619
South AfricaSite Not Available
Research Site 90027-006
Pretoria, Gauteng 0184
South AfricaSite Not Available
Research Site 90027-009
Witbank, Gauteng 1035
South AfricaSite Not Available
Research Site 90027-001
Cape Town, Western Cape 7500
South AfricaSite Not Available
Research Site 11027-007
Kuilsrivier, Western Cape 7580
South AfricaSite Not Available
Research Site 11027-013
Paarl, Western Cape 7646
South AfricaSite Not Available
Research Site 90027-004
Somerset West, Western Cape 7130
South AfricaSite Not Available
Research Site 90027-005
Somerset West, Western Cape 7130
South AfricaSite Not Available
Research Site 90034-004
Córdoba, Andalucia 14004
SpainSite Not Available
Research Site 90034-002
Zaragoza, Aragon 5009
SpainSite Not Available
Research Site 90034-005
Barcelona, Cataluna 08036
SpainSite Not Available
Research Site 90034-006
Barcelona, Cataluna 08907
SpainSite Not Available
Research Site 90034-001
Reus, Cataluna 43204
SpainSite Not Available
Research Site 90034-003
La Coruña, Galicia 15002
SpainSite Not Available
Research Site 90034-003
A Coruña,
SpainSite Not Available
Research Site 90046-002
Göteborg, SE-41346
SwedenSite Not Available
Research Site 90046-001
Stockholm, SE-11446
SwedenSite Not Available
Research Site 90046-003
Stockholm, SE-14186
SwedenSite Not Available
Research Site 11380-005
Cherkasy,
UkraineSite Not Available
Research Site 11380-008
Kharkiv, 61176
UkraineSite Not Available
Research Site 11380-001
Kyiv, 02002
UkraineSite Not Available
Research Site 11380-002
Kyiv, 03037
UkraineSite Not Available
Research Site 11380-003
Kyiv, 03049
UkraineSite Not Available
Research Site 11380-004
Kyiv,
UkraineSite Not Available
Research Site 11380-009
Zaporizhzhya,
UkraineSite Not Available
Research Site 11380-006
Úzhgorod, 88000
UkraineSite Not Available
Research Site 11044-028
Bollington, Cheshire SK10 5JH
United KingdomSite Not Available
Research Site 11044-012
Liskeard, Cornwall PL14 3XA
United KingdomSite Not Available
Research Site 11044-026
Bury,
United KingdomSite Not Available
Research Site 11044-024
Cheadle Hulme,
United KingdomSite Not Available
Research Site 11044-014
Chorley,
United KingdomSite Not Available
Research Site 11044-012
Cornwell,
United KingdomSite Not Available
Research Site 11044-010
Derby,
United KingdomSite Not Available
Research Site 11044-006
Edgbaston,
United KingdomSite Not Available
Research Site 11044-009
Exeter,
United KingdomSite Not Available
Research Site 11044-001
Glasgow,
United KingdomSite Not Available
Research Site 11044-008
Hexham,
United KingdomSite Not Available
Research SIte 11044-020
Macclesfield,
United KingdomSite Not Available
Research Site 11044-005
Manchester,
United KingdomSite Not Available
Research Site 11044-025
Manchester,
United KingdomSite Not Available
Research Site 11044-027
Manchester,
United KingdomSite Not Available
Research Site 11044-029
Manchester,
United KingdomSite Not Available
Research Site 11044-019
Plymouth,
United KingdomSite Not Available
Research Site 11044-003
Reading,
United KingdomSite Not Available
Research Site 11044-022
Sale,
United KingdomSite Not Available
Research Site 11044-023
Sale,
United KingdomSite Not Available
Research Site 11044-002
Stockton-on-Tees,
United KingdomSite Not Available
Research Site 11044-021
Timperley,
United KingdomSite Not Available
Research Site 11044-007
Wales,
United KingdomSite Not Available
Research Site 11044-004
Waterloo,
United KingdomSite Not Available
Research Site 10001-015
Birmingham, Alabama 35211
United StatesSite Not Available
Research Site 10001-138
Foley, Alabama 36535
United StatesSite Not Available
Research Site 10001-113
Huntsville, Alabama 35801
United StatesSite Not Available
Research Site 10001-058
Mobile, Alabama 36608
United StatesSite Not Available
Research Site 10001-037
Montgomery, Alabama 36117
United StatesSite Not Available
Research Site 10001-076
Saraland, Alabama 36571
United StatesSite Not Available
Research Site 10001-013
Chandler, Arizona 85224
United StatesSite Not Available
Research Site 10001-077
Mesa, Arizona 85213
United StatesSite Not Available
Research Site 10001-136
Phoenix, Arizona 85014
United StatesSite Not Available
Research Site 10001-051
Surprise, Arizona 85374
United StatesSite Not Available
Research Site 10001-004
Tucson, Arizona 85741
United StatesSite Not Available
Research Site 10001-019
Tucson, Arizona 85712
United StatesSite Not Available
Research Site 10001-132
Tucson, Arizona 85745
United StatesSite Not Available
Research Site 10001-073
Beverly Hills, California 90211
United StatesSite Not Available
Research Site 10001-050
Canoga Park, California 91303
United StatesSite Not Available
Research Site 10001-011
Carlsbad, California 92008
United StatesSite Not Available
Research Site 10001-065
El Cajon, California 92020
United StatesSite Not Available
Research Site 10001-150
Los Angeles, California 90022
United StatesSite Not Available
Research Site 90001-005
Mission Viejo, California 92691
United StatesSite Not Available
Research Site 10001-022
Northridge, California 91325
United StatesSite Not Available
Research Site 10001-043
Northridge, California 91324
United StatesSite Not Available
Research Site 10001-033
Sacramento, California 95821-2134
United StatesSite Not Available
Research Site 10001-105
San Ramon, California 94582
United StatesSite Not Available
Research Site 10001-008
Santa Rosa, California 95405
United StatesSite Not Available
Research Site 10001-153
Spring Valley, California 91978
United StatesSite Not Available
Research Site 90001-015
Stanford, California 94305
United StatesSite Not Available
Research Site 10001-044
Torrance, California 90502
United StatesSite Not Available
Research Site 90001-047
Boca Raton, Florida 33434
United StatesSite Not Available
Research Site 10001-084
Clearwater, Florida 33756
United StatesSite Not Available
Research Site 10001-099
Clearwater, Florida 33761
United StatesSite Not Available
Research Site 10001-155
Clearwater, Florida 33756
United StatesSite Not Available
Research Site 10001-127
Daytona Beach, Florida 32117
United StatesSite Not Available
Research Site 10001-119
Fleming Island, Florida 32003
United StatesSite Not Available
Research Site 10001-070
Fort Lauderdale, Florida 33308
United StatesSite Not Available
Research Site 10001-067
Hialeah, Florida 33012
United StatesSite Not Available
Research Site 10001-039
Jacksonville, Florida 32216
United StatesSite Not Available
Research Site 10001-098
Jacksonville, Florida 32216
United StatesSite Not Available
Research Site 10001-139
Jacksonville, Florida 32204
United StatesSite Not Available
Research Site 10001-030
Miami, Florida 33165
United StatesSite Not Available
Research Site 10001-081
Miami, Florida 33126
United StatesSite Not Available
Research Site 10001-116
Miami, Florida 33183
United StatesSite Not Available
Research Site 10001-140
Miami, Florida 33126
United StatesSite Not Available
Research Site 10001-142
Miami, Florida 33126
United StatesSite Not Available
Research Site 10001-080
Miami Springs, Florida 33166
United StatesSite Not Available
Research Site 10001-027
Pembroke Pines, Florida 33024
United StatesSite Not Available
Research Site 10001-048
Pembroke Pines, Florida 33029
United StatesSite Not Available
Research Site 10001-115
Pembroke Pines, Florida 33027
United StatesSite Not Available
Research Site 10001-147
Pembroke Pines, Florida 33029
United StatesSite Not Available
Research Site 10001-003
Pinellas Park, Florida 33781
United StatesSite Not Available
Research Site 10001-104
Ponte Vedra, Florida 32081
United StatesSite Not Available
Research Site 10001-090
Saint Augustine, Florida 32086
United StatesSite Not Available
Research Site 10001-102
Saint Petersburg, Florida 33713
United StatesSite Not Available
Research Site 10001-123
Sarasota, Florida 34239-3513
United StatesSite Not Available
Research Site 10001-143
Tampa, Florida 33614
United StatesSite Not Available
Research Site 10001-069
Atlanta, Georgia 30342
United StatesSite Not Available
Research Site 10001-086
Calhoun, Georgia 30701
United StatesSite Not Available
Research Site 10001-131
Decatur, Georgia 30030
United StatesSite Not Available
Research Site 10001-137
Dunwoody, Georgia 30338
United StatesSite Not Available
Research Site 10001-092
Macon, Georgia 31210
United StatesSite Not Available
Research Site 10001-059
Arlington Heights, Illinois 60005
United StatesSite Not Available
Research Site 10001-158
Chicago, Illinois 60652
United StatesSite Not Available
Research Site 10001-036
Evanston, Illinois 60201
United StatesSite Not Available
Research Site 10001-082
Indianapolis, Indiana 46260
United StatesSite Not Available
Research Site 1001-020
Sellersburg, Indiana 47172
United StatesSite Not Available
Research Site 10001-040
Valparaiso, Indiana 46383
United StatesSite Not Available
Research Site 10001-074
West Des Moines, Iowa 50266
United StatesSite Not Available
Research Site 10001-028
Hutchinson, Kansas 67502
United StatesSite Not Available
Research Site 10001-108
Lexington, Kentucky 40504
United StatesSite Not Available
Research Site 10001-125
Lexington, Kentucky 40503
United StatesSite Not Available
Research Site 10001-107
Owensboro, Kentucky 42303
United StatesSite Not Available
Research Site 10001-144
Crowley, Louisiana 70526
United StatesSite Not Available
Research Site 10001-041
Lake Charles, Louisiana 70601
United StatesSite Not Available
Research Site 10001-101
Monroe, Louisiana 71201
United StatesSite Not Available
Research Site 90001-004
Boston, Massachusetts 02114
United StatesSite Not Available
Research Site 10001-024
Flint, Michigan 48504
United StatesSite Not Available
Research Site 10001-095
Grandville, Michigan 49418
United StatesSite Not Available
Research Site 10001-078
Sterling Heights, Michigan 48310
United StatesSite Not Available
Research Site 10001-034
Troy, Michigan 48098
United StatesSite Not Available
Research Site 10001-018
Edina, Minnesota 55435
United StatesSite Not Available
Research Site 10001-096
Minneapolis, Minnesota 55407
United StatesSite Not Available
Research Site 90001-056
Saint Paul, Minnesota 55102
United StatesSite Not Available
Research Site 10001-007
Saint Louis, Missouri 63141
United StatesSite Not Available
Research Site 10001-156
Saint Louis, Missouri 63136
United StatesSite Not Available
Research Site 90001-012
Butte, Montana 59701
United StatesSite Not Available
Research Site 10001-021
Omaha, Nebraska 68144
United StatesSite Not Available
Research Site 10001-053
Omaha, Nebraska 68134
United StatesSite Not Available
Research Site 10001-124
Las Vegas, Nevada 89121
United StatesSite Not Available
Research Site 90001-112
Las Vegas, Nevada 89119
United StatesSite Not Available
Research Site 10001-060
Bridgewater, New Jersey 08807
United StatesSite Not Available
Research Site 90001-014
Summit, New Jersey 07901
United StatesSite Not Available
Research Site 10001-055
Warren, New Jersey 07059
United StatesSite Not Available
Research Site 10001-054
Albany, New York 12206
United StatesSite Not Available
Research Site 10001-122
Binghamton, New York 13901
United StatesSite Not Available
Research Site 10001-128
Endwell, New York 13760
United StatesSite Not Available
Research Site 10001-042
New Windsor, New York 12553
United StatesSite Not Available
Research Site 10001-129
Poughkeepsie, New York 12601
United StatesSite Not Available
Research Site 10001-110
Williamsville, New York 14221
United StatesSite Not Available
Research Site 10001-063
Cary, North Carolina 27518
United StatesSite Not Available
Research Site 10001-064
Greensboro, North Carolina 27401
United StatesSite Not Available
Research Site 10001-145
Mooresville, North Carolina 28117
United StatesSite Not Available
Research Site 10001-046
Shelby, North Carolina 28150
United StatesSite Not Available
Research Site 10001-016
Akron, Ohio 443311
United StatesSite Not Available
Research Site 10001-010
Cincinnati, Ohio 45236
United StatesSite Not Available
Research Site 10001-120
Cincinnati, Ohio 45219
United StatesSite Not Available
Research Site 10001-134
Cincinnati, Ohio 45246
United StatesSite Not Available
Research Site 90001-002
Cincinnati, Ohio 45227
United StatesSite Not Available
Research Site 10001-014
Columbus, Ohio 43212
United StatesSite Not Available
Research Site 10001-141
Dayton, Ohio 45419
United StatesSite Not Available
Research Site 10001-148
Marion, Ohio 43302
United StatesSite Not Available
Research Site 10001-017
Edmond, Oklahoma 73003
United StatesSite Not Available
Research Site 10001-151
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
Research Site 10001-109
Wyomissing, Pennsylvania 19610
United StatesSite Not Available
Research Site 10001-001
Anderson, South Carolina 29621
United StatesSite Not Available
Research Site 10001-062
Greenville, South Carolina 29615
United StatesSite Not Available
Research Site 10001-006
Greer, South Carolina 29651
United StatesSite Not Available
Research Site 10001-075.
Greer, South Carolina 29651
United StatesSite Not Available
Research Site 10001-111
Myrtle Beach, South Carolina 29588
United StatesSite Not Available
Research Site 10001-133
Pelzer, South Carolina 29669
United StatesSite Not Available
Research Site 10001-026
Spartanburg, South Carolina 29303
United StatesSite Not Available
Research Site 10001-103
Rapid City, South Dakota 57701
United StatesSite Not Available
Research Site 10001-146
Athens, Tennessee 37303
United StatesSite Not Available
Research Site 10001-152
Greeneville, Tennessee 37745
United StatesSite Not Available
Research Site 10001-130
Kingsport, Tennessee 37660
United StatesSite Not Available
Research Site 10001-106
Knoxville, Tennessee 37917
United StatesSite Not Available
Research Site 10001-118
Knoxville, Tennessee 37909
United StatesSite Not Available
Research Site 10001-100
Amarillo, Texas 79106
United StatesSite Not Available
Research Site 10001-087
Austin, Texas 78726
United StatesSite Not Available
Research Site 10001-117
Austin, Texas 78756
United StatesSite Not Available
Research Site 10001-009
Dallas, Texas 75234
United StatesSite Not Available
Research Site 10001-068
Edinburg, Texas 78503
United StatesSite Not Available
Research Site 10001-126
Fort Worth, Texas 76106
United StatesSite Not Available
Research Site 10001-031
Houston, Texas 77002
United StatesSite Not Available
Research Site 10001-032
Houston, Texas 77070
United StatesSite Not Available
Research Site 10001-061
Houston, Texas 77058
United StatesSite Not Available
Research Site 10001-088
Houston, Texas 77024
United StatesSite Not Available
Research Site 10001-091
Houston, Texas 77027
United StatesSite Not Available
Research Site 10001-025
Lubbock, Texas 79410
United StatesSite Not Available
Research Site 10001-057
New Braunfels, Texas 78130
United StatesSite Not Available
Research Site 10001-079
Round Rock, Texas 78681
United StatesSite Not Available
Research Site 10001-071
San Antonio, Texas 78229
United StatesSite Not Available
Research Site 10001-083
Schertz, Texas 78154
United StatesSite Not Available
Research Site 10001-149
Shavano Park, Texas 78231
United StatesSite Not Available
Research Site 10001-045
Tomball, Texas 77375
United StatesSite Not Available
Research Site 10001-005
Layton, Utah 84041
United StatesSite Not Available
Research Site 10001-002
Salt Lake City, Utah 84123
United StatesSite Not Available
Research Site 10001-052
Salt Lake City, Utah 94107
United StatesSite Not Available
Research Site 10001-093
Falls Church, Virginia 22042
United StatesSite Not Available
Research Site 10001-085
Manassas, Virginia 20110
United StatesSite Not Available
Research Site 10001-094
Midlothian, Virginia 23114
United StatesSite Not Available
Research Site 10001-023
Richmond, Virginia 23294
United StatesSite Not Available
Research Site 10001-029
Suffolk, Virginia 23435
United StatesSite Not Available
Research Site 10001-114
Tacoma, Washington 98405
United StatesSite Not Available
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