Status:
COMPLETED
Inclisiran for Subjects With ASCVD or ASCVD-Risk Equivalents and Elevated Low-density Lipoprotein Cholesterol
Lead Sponsor:
The Medicines Company
Conditions:
ASCVD
Risk Factor, Cardiovascular
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a Phase III, placebo-controlled, double-blind, randomized study in participants with ASCVD or ASCVD-Risk equivalents and elevated LDL-C despite maximum tolerated dose of LDL-C lowering therapi...
Eligibility Criteria
Inclusion
- Participants may be included if they meet all of the following inclusion criteria prior to randomization:
- 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.
- Calculated glomerular filtration rate \>30 mL/min by estimated glomerular filtration rate (eGFR) using standardized clinical methodology
- 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.
- Subjects were willing and able to give informed consent before initiation of any study-related procedures and willing to comply with all required study procedures
Exclusion
- Participants will be excluded from the study if any of the following exclusion criteria apply prior to randomization:
- 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 :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 27 2019
Estimated Enrollment :
1617 Patients enrolled
Trial Details
Trial ID
NCT03400800
Start Date
November 1 2017
End Date
August 27 2019
Last Update
August 21 2020
Active Locations (70)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site 11420-002
Chomutov, Czechia, 43001
2
Research Site 11420-003
Uherské Hradiště, Czechia, 68601
3
Research Site 11049-006
Berlin, Germany, 12567
4
Research Site 11049-002
Bochum, Germany, 44787