Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 3

Reduction of LDL-C With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study-2

NCT01763918 · View on ClinicalTrials.gov ↗

Study Summary

The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneously once every 2 weeks (Q2W) and once monthly (QM), compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in adults with heterozygous familial hypercholesterolemia (HeFH).

Conditions Studied

Interventions

  • DRUG Placebo
  • BIOLOGICAL Evolocumab

Study Locations (20)

Other

  • Research Site — Bron
  • Research Site — Nantes
  • Research Site — Paris
  • Research Site — Cologne
  • Research Site — New Territories
  • Research Site — Amersfoort
  • Research Site — Amsterdam
  • Research Site — Amsterdam
  • Research Site — Gouda
  • Research Site — Groningen
  • Research Site — Hoorn

Quebec

  • Research Site — Chicoutimi
  • Research Site — Montreal
  • Research Site — Montreal

Arizona

  • Research Site — Scottsdale

Ohio

  • Research Site — Cincinnati

New South Wales

  • Research Site — Camperdown

Western Australia

  • Research Site — Perth

British Columbia

  • Research Site — Vancouver

Ontario

  • Research Site — London

Trial Details

FieldValue
Enrollment Target 331 participants
Start Date 2013-02-07
Est. Completion 2013-12-19
Phase Phase 3

Sponsor

Amgen

266 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01763918

The ClinicalTrials.gov registry entry for NCT01763918 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 331 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 266 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Hyperlipidemia appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01763918 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Other, Quebec, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01763918 about?

NCT01763918 is a clinical study titled "Reduction of LDL-C With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study-2". The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneously once every 2 weeks (Q2W) and once monthly (QM), compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in adults with heterozygous familial hypercholesterolemia (H...

What is the current status of trial NCT01763918?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 331 participants. The study started on 2013-02-07. Estimated completion is 2013-12-19.

What conditions does trial NCT01763918 study?

This clinical trial studies the following conditions: Hyperlipidemia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01763918?

The interventions under investigation include: Placebo (DRUG), Evolocumab (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01763918?

This trial is sponsored by Amgen, which has 266 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01763918 being conducted?

This trial has 20 study locations across Arizona, Ohio, New South Wales, Western Australia, British Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial