Status:
COMPLETED
Trial to Evaluate the Effect of Inclisiran Treatment on Low Density Lipoprotein Cholesterol (LDL-C) in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH)
Lead Sponsor:
The Medicines Company
Conditions:
Heterozygous Familial Hypercholesterolemia
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 HeFH and elevated LDL-C to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) injection(s...
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 HeFH with a diagnosis of HeFH by genetic testing; and/or a documented history of untreated LDL-C of \>190 mg/dL, and a family history of familial hypercholesterolemia, elevated cholesterol or early heart disease that may indicate familial hypercholesterolemia.
- Serum LDL-C ≥2.6 millimoles (mmol)/liter (L) (≥100 mg/dL) at screening.
- 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.
- Participants on lipid-lowering 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
- Participants will be excluded from the study if any of the following exclusion criteria apply immediately 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) (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 (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 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 17 2019
Estimated Enrollment :
482 Patients enrolled
Trial Details
Trial ID
NCT03397121
Start Date
November 28 2017
End Date
September 17 2019
Last Update
October 28 2020
Active Locations (45)
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1
Site 90001-005
Mission Viejo, California, United States, 92691
2
Site 90001-001
Newport Beach, California, United States, 92663
3
Site 90001-015
Stanford, California, United States, 94305
4
Site 90001-047
Boca Raton, Florida, United States, 33434