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COMPLETED Phase 2

Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects

NCT01375764 · View on ClinicalTrials.gov ↗

Study Summary

The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients with hypercholesterolemia unable to tolerate an effective dose of a statin.

Conditions Studied

Interventions

  • DRUG Ezetimibe
  • BIOLOGICAL Evolocumab
  • OTHER Placebo to Evolocumab

Study Locations (20)

California

  • Research Site — Anaheim
  • Research Site — Mission Viejo
  • Research Site — Westlake Village

Georgia

  • Research Site — Atlanta
  • Research Site — Atlanta
  • Research Site — Savannah

Nevada

  • Research Site — Henderson
  • Research Site — Las Vegas

Ohio

  • Research Site — Akron
  • Research Site — Cincinnati

New South Wales

  • Research Site — Camperdown
  • Research Site — Sydney

Maine

  • Research Site — Auburn

Maryland

  • Research Site — Chevy Chase

Montana

  • Research Site — Butte

Trial Details

FieldValue
Enrollment Target 160 participants
Start Date 2011-07-28
Est. Completion 2012-05-08
Phase Phase 2

Sponsor

Amgen

266 total trials

Interested in This Trial?

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01375764

The ClinicalTrials.gov registry entry for NCT01375764 describes a study currently listed as completed. It is categorized as Phase 2, 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 160 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 3 interventions — of which Ezetimibe 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: NCT01375764 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Georgia, Nevada. 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 NCT01375764 about?

NCT01375764 is a clinical study titled "Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects". The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients with hypercholesterolemia unable to tolerate an effective dose of a statin.

What is the current status of trial NCT01375764?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 160 participants. The study started on 2011-07-28. Estimated completion is 2012-05-08.

What conditions does trial NCT01375764 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 NCT01375764?

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

Who is sponsoring clinical trial NCT01375764?

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 NCT01375764 being conducted?

This trial has 20 study locations across California, Georgia, Maine, Maryland, Montana. 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