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



Status:Active, not recruiting
Conditions:High Cholesterol, Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:2/23/2019
Start Date:December 21, 2017
End Date:December 2019

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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)

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.


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.
We found this trial at
113
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Saraland, Alabama 36571
1753
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Saraland, AL
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Akron, Ohio 44331
2040
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Albany, New York 12206
2440
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Amarillo, Texas 79106
922
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Anderson, South Carolina 29621
2008
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Arlington Heights, Illinois 60005
1610
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Athens, Tennessee 37303
1890
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Atlanta, Georgia 30342
1919
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13729 Research Boulevard
Austin, Texas 78758
1205
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Beverly Hills, California 90211
22
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Binghamton, New York 13901
2330
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Birmingham, Alabama 35211
1785
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Boca Raton, Florida 33434
2312
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Bridgewater, New Jersey 08807
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Canoga Park, California 91303
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Carlsbad, California 92008
73
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Cary, North Carolina 27518
2210
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Chandler, Arizona 85224
358
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Chicago, Illinois 60616
1728
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Cincinnati, Ohio 45219
1882
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Clearwater, Florida 33756
2116
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Columbus, Ohio 43212
1960
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Crowley, Louisiana 70526
1519
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Dallas, Texas 75230
1223
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Dayton, Ohio 45419
1897
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Daytona Beach, Florida 32117
2189
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Dunwoody, Georgia 30338
1920
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Edina, Minnesota 55435
1503
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Edinburg, Texas 78503
1298
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Edmond, Oklahoma 73003
1167
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El Cajon, California 92020
107
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Endwell, New York 13760
2325
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Evanston, Illinois 60201
1728
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Falls Church, Virginia 22042
2274
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Fleming Island, Florida 32003
2131
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Flint, Michigan 48504
1939
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Foley, Alabama 36535
1783
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Fort Lauderdale, Florida 33308
2315
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1195
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Grandville, Michigan 49418
1834
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Greensboro, North Carolina 27401
2151
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Greer, South Carolina 29651
2027
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Hialeah, Florida 33012
2314
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Houston, Texas 77090
1358
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Huntsville, Alabama 35801
1784
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Hutchinson, Kansas 67502
1152
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Indianapolis, Indiana 46254
1787
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Jacksonville, Florida 32204
2130
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105 West Stone Drive
Kingsport, Tennessee 37660
1995
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Knoxville, Tennessee 37909
1923
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Lake Charles, Louisiana 70601
1469
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217
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Layton, Utah 84041
584
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Lexington, Kentucky 40503
1879
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13
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Lubbock, Texas 79410
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Macon, Georgia 31210
1974
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Manassas, Virginia 20110
2258
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Marion, Ohio 43302
1955
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Mesa, Arizona 85213
358
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Miami, Florida 33156
2319
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Miami Springs, Florida 33166
2315
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Midlothian, Virginia 23114
2257
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Mobile, Alabama 36608
1757
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Monroe, Louisiana 71201
1495
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Montgomery, Alabama 36117
1829
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Mooresville, North Carolina 28117
2099
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Myrtle Beach, South Carolina 29588
2230
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New Braunfels, Texas 78130
1203
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New Windsor, New York 12553
2429
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Northridge, California 91324
31
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Omaha, Nebraska 68131
1301
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Owensboro, Kentucky 42303
1739
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Pelzer, South Carolina 29669
2017
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Pembroke Pines, Florida 33024
2314
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Phoenix, Arizona 85014
343
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Pinellas Park, Florida 33781
2125
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Ponte Vedra, Florida 32081
2147
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Poughkeepsie, New York 12601
2433
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Powell, Texas 37849
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Rapid City, South Dakota 57701
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Raritan, New Jersey 08869
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Richmond, Virginia 23294
2267
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Round Rock, Texas 78681
1210
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3750 Auburn Boulevard
Sacramento, California 95821
366
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Saint Augustine, Florida 32086
2158
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41 1st Avenue
Saint Louis, Missouri 63136
1633
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Saint Paul, Minnesota 55102
1516
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Saint Petersburg, Florida 33713
2128
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436 State Capitol
Salt Lake City, Utah 84101
571
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San Antonio, Texas 78229
1182
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San Ramon, California 94582
338
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2301 Hardies Lane
Santa Rosa, California 95403
401
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Sarasota, Florida 34239
2147
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Schertz, Texas 78154
1198
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Sellersburg, Indiana 47172
1812
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Shavano Park, Texas 78231
1181
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Shelby, North Carolina 28150
2062
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Spartanburg, South Carolina 29303
2043
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Spring Valley, California 91978
324
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Sterling Heights, Michigan 48310
1969
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