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

NCT01763866 · ClinicalTrials.gov registry record · Phase 3

LDL-C Assessment With PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy-2

A Phase 3 study, sponsored by Amgen.

Completed
Registry status
Phase 3
Development phase
2,067
Enrollment target

NCT01763866: Completed Phase 3 study, sponsored by Amgen.

NCT01763866 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 2,067 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (168% higher). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT01763866, a Phase 3 study, has completed, sponsored by Amgen.

COMPLETED
Registry status
Phase 3
Development phase
2,067 participants
Enrollment target

Study Summary

The primary objective was to evaluate the effect of 12 weeks of evolocumab administered subcutaneously every 2 weeks (Q2W) and monthly (QM) when used in combination with a statin, compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia.

Interventions

  • DRUG Ezetimibe
  • DRUG Atorvastatin
  • BIOLOGICAL Evolocumab
  • DRUG Placebo to Evolocumab
  • DRUG Placebo to Ezetimibe

Trial Details

FieldValue
Enrollment Target 2,067 participants
Start Date 2013-01-15
Est. Completion 2013-12-04
Phase Phase 3
Amgen

558 total trials

What the finished NCT01763866 record still lists

NCT01763866 is an interventional study that assigns participants to a tested intervention. Its 2,067 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (168% higher).

The record links to 0 conditions, and to 5 interventions - of which Ezetimibe is the first listed.

NCT01763866 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01763866 about?

NCT01763866 is a clinical study titled "LDL-C Assessment With PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy-2". The primary objective was to evaluate the effect of 12 weeks of evolocumab administered subcutaneously every 2 weeks (Q2W) and monthly (QM) when used in combination with a statin, compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients with p...

What is the current status of trial NCT01763866?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,067 participants. The study started on 2013-01-15. Estimated completion is 2013-12-04.

What interventions are being tested in trial NCT01763866?

The interventions under investigation include: Ezetimibe (DRUG), Atorvastatin (DRUG), Evolocumab (BIOLOGICAL), Placebo to Evolocumab (DRUG), Placebo to Ezetimibe (DRUG).

Who is sponsoring clinical trial NCT01763866?

This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01763866's enrollment target sits among peer trials

2,067 99th of 2000 higher than 1,902 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT06666192 · 2,067 participants · NA

    The Ohio State University (OSU) SCREEN Community Program

  • NCT00588068 · 2,070 participants

    Molecular Characterization of Neuroblastic Tumor: Correlation With Clinical Outcome

  • NCT07168993 · 2,063 participants · NA

    Evaluate the Clinical Performance of the Flow Cytometry - FlowPath Lung Test as a Sensitive and Specific Non-invasive Diagnostic of Sputum Samples to Identify/Detect the Presence of Lung Cancer in High-risk Individuals Who Have Existing Lung Nodules, 6 to <30 mm in Diameter, Determined by LDCT.

  • NCT04871542 · 2,062 participants

    Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Source: ClinicalTrials.gov NCT01763866, the US trial registry maintained by the National Library of Medicine. NCT01763866 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.