Trial to Evaluate the Effect of Inclisiran Treatment on Low Density Lipoprotein Cholesterol (LDL-C) in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH)

Part of paid clinical trials in Mission Viejo, California.

Sponsor
The Medicines Company
Study ID
NCT03397121
Phase
PHASE3
Status
Completed

Conditions

  • Elevated Cholesterol
  • Heterozygous Familial Hypercholesterolemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Inclisiran — DRUG
    Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.
  • Placebo — DRUG
    Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection).

Study Details

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) of inclisiran. The study will be multicenter and international.

Key Dates

Start date
Nov 28, 2017
Status verified
Oct 2020
Primary completion
Aug 27, 2019
Completion
Sep 17, 2019

Study Design

Enrollment
482 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Inclisiran
    Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection on Day 1, Day 90 then every 6 months.
  • Placebo Comparator: Placebo
    Placebo will be administered as SC injections of saline solution on Day 1, Day 90 then every 6 months.

Primary Outcome Measure

Percent Change in LDL-C From Baseline To Day 510 [ Time Frame: Baseline, Day 510 ]

Locations (10)

FacilityCityStateZIPSite coordinators
Site 90001-005Mission ViejoCalifornia92691-
Site 90001-001Newport BeachCalifornia92663-
Site 90001-015StanfordCalifornia94305-
Site 90001-047Boca RatonFlorida33434-
Site 90001-004BostonMassachusetts02114-
Site 90001-056Saint PaulMinnesota55102-
Site 90001-012ButteMontana59701-
Site 90001-112Las VegasNevada89119-
Site 90001-014SummitNew Jersey07901-
Site 90001-002CincinnatiOhio45227-

Find similar trials in Mission Viejo, CA

By research site
Site 90001-005· Mission Viejo, CASite 90001-001· Newport Beach, CASite 90001-015· Stanford, CASite 90001-047· Boca Raton, FLSite 90001-004· Boston, MASite 90001-056· Saint Paul, MN

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