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NCT01926782 · ClinicalTrials.gov registry record · Phase 3

Study to Evaluate the Efficacy and Safety of an Every Four Weeks Treatment Regimen of Alirocumab (REGN727/ SAR236553) in Patients With Primary Hypercholesterolemia (ODYSSEY CHOICE 1)

A Phase 3 study of Hypercholesterolemia, sponsored by Regeneron Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
803
Enrollment target
20
Study locations

NCT01926782 is a Phase 3 study of Hypercholesterolemia that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 803 participants, roughly in line with the 804-participant average among 62 other Hypercholesterolemia trials with a reported enrollment target. The trial reports 20 study locations across 10 states.

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The verdict

NCT01926782, a Phase 3 study of Hypercholesterolemia, has completed, sponsored by Regeneron Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
803 participants
Enrollment target
20
Study locations

Study Summary

To determine the efficacy, long-term safety, and tolerability of alirocumab 300 mg every 4 weeks (Q4W), in comparison with placebo, as well as its potential as a starting regimen. The dose regimen of 75 mg every 2 weeks (Q2W), as used in other studies, was added as a calibrator.

Conditions Studied

Hypercholesterolemia

Interventions

  • DRUG Statin
  • DRUG Alirocumab
  • DRUG Placebo (for alirocumab)

Study Locations (20)

California

  • - Carmichael
  • - Fresno
  • - West Hills
  • - Wildomar

Florida

  • - Boynton Beach
  • - Jacksonville
  • - Safety Harbor

Arizona

  • - Chandler
  • - Goodyear

Colorado

  • - Colorado Springs
  • - Golden

Idaho

  • - Boise
  • - Meridian

Illinois

  • - Chicago
  • - Gurnee

Indiana

  • - Evansville
  • - Indianapolis

Georgia

  • - Atlanta

Trial Details

FieldValue
Enrollment Target 803 participants
Start Date 2013-09
Est. Completion 2015-04
Phase Phase 3

Sponsor

Regeneron Pharmaceuticals

280 total trials

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What the Registry Record Tells You About NCT01926782

The ClinicalTrials.gov registry entry for NCT01926782 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 803 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 804-participant average among 62 other Hypercholesterolemia trials with a reported enrollment target. The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Hypercholesterolemia appearing as the primary indexed condition, and to 3 interventions - of which Statin is the first listed.

NCT01926782 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, Florida, Arizona.

Frequently Asked Questions

What is clinical trial NCT01926782 about?

NCT01926782 is a clinical study titled "Study to Evaluate the Efficacy and Safety of an Every Four Weeks Treatment Regimen of Alirocumab (REGN727/ SAR236553) in Patients With Primary Hypercholesterolemia (ODYSSEY CHOICE 1)". To determine the efficacy, long-term safety, and tolerability of alirocumab 300 mg every 4 weeks (Q4W), in comparison with placebo, as well as its potential as a starting regimen. The dose regimen of 75 mg every 2 weeks (Q2W), as used in other studies, was added as a calibrator.

What is the current status of trial NCT01926782?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 803 participants. The study started on 2013-09. Estimated completion is 2015-04.

What conditions does trial NCT01926782 study?

This clinical trial studies the following conditions: Hypercholesterolemia.

What interventions are being tested in trial NCT01926782?

The interventions under investigation include: Statin (DRUG), Alirocumab (DRUG), Placebo (for alirocumab) (DRUG).

Who is sponsoring clinical trial NCT01926782?

This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01926782 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.