Status:
COMPLETED
Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol
Lead Sponsor:
The Medicines Company
Conditions:
ASCVD
Elevated Cholesterol
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 efficac...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 17 2019
Estimated Enrollment :
1561 Patients enrolled
Trial Details
Trial ID
NCT03399370
Start Date
December 21 2017
End Date
September 17 2019
Last Update
October 5 2020
Active Locations (145)
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1
Research Site 10001-015
Birmingham, Alabama, United States, 35211
2
Research Site 10001-138
Foley, Alabama, United States, 36535
3
Research Site 10001-113
Huntsville, Alabama, United States, 35801
4
Research Site 10001-058
Mobile, Alabama, United States, 36608