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NCT01954394 · ClinicalTrials.gov registry record · Phase 3

Open Label Study of Long Term Safety Evaluation of Alirocumab

A Phase 3 study of Hypercholesterolemia, sponsored by Sanofi.

Completed
Registry status
Phase 3
Development phase
986
Enrollment target
20
Study locations

NCT01954394 is a Phase 3 study of Hypercholesterolemia that has completed, run by Sanofi. The registered enrollment target is 986 participants, above the 801-participant average among 62 other Hypercholesterolemia trials with a reported enrollment target (23% higher). The trial reports 20 study locations across 10 states.

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The verdict

NCT01954394, a Phase 3 study of Hypercholesterolemia, has completed, sponsored by Sanofi.

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

Study Summary

Primary Objective: To assess the long-term safety of alirocumab (SAR236553/REGN727) when added to lipid-lowering therapy in participants with heterozygous familial hypercholesterolemia (heFH) who had completed EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500), EFC12732 (NCT01617655) and LTS11717 (NCT01507831). Secondary Objectives: * To evaluate the long-term efficacy of alirocumab on lipid parameters. * To evaluate the long-term immunogenicity of alirocumab.

Conditions Studied

Hypercholesterolemia

Interventions

  • DRUG Alirocumab
  • DRUG Lipid-Modifying Therapy (LMT)

Study Locations (20)

Florida

  • Investigational Site Number 840344 - Atlantis
  • Investigational Site Number 840353 - Clearwater
  • Investigational Site Number 840318 - Fort Lauderdale
  • Investigational Site Number 840327 - Jacksonville
  • Investigational Site Number 840309 - Miami
  • Investigational Site Number 840351 - Sarasota

California

  • Investigational Site Number 840334 - Bell Gardens
  • Investigational Site Number 840319 - Fountain Valley
  • Investigational Site Number 840336 - Los Angeles
  • Investigational Site Number 840339 - Mission Viejo
  • Investigational Site Number 840337 - Newport Beach

Illinois

  • Investigational Site Number 840315 - Evanston
  • Investigational Site Number 840305 - Oakbrook Terrace

Alabama

  • Investigational Site Number 840321 - Huntsville

Arizona

  • Investigational Site Number 840341 - Tempe

Colorado

  • Investigational Site Number 840306 - Golden

District of Columbia

  • Investigational Site Number 840328 - Washington D.C.

Iowa

  • Investigational Site Number 840333 - Iowa City

Trial Details

FieldValue
Enrollment Target 986 participants
Start Date 2013-12-17
Est. Completion 2017-06-30
Phase Phase 3

Sponsor

Sanofi

713 total trials

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What the Registry Record Tells You About NCT01954394

The ClinicalTrials.gov registry entry for NCT01954394 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 986 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 801-participant average among 62 other Hypercholesterolemia trials with a reported enrollment target (23% higher). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Hypercholesterolemia appearing as the primary indexed condition, and to 2 interventions - of which Alirocumab is the first listed.

NCT01954394 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Florida, California, Illinois.

Frequently Asked Questions

What is clinical trial NCT01954394 about?

NCT01954394 is a clinical study titled "Open Label Study of Long Term Safety Evaluation of Alirocumab". Primary Objective: To assess the long-term safety of alirocumab (SAR236553/REGN727) when added to lipid-lowering therapy in participants with heterozygous familial hypercholesterolemia (heFH) who had completed EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500), EFC12732 (NCT01617655) and LTS11717 (...

What is the current status of trial NCT01954394?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 986 participants. The study started on 2013-12-17. Estimated completion is 2017-06-30.

What conditions does trial NCT01954394 study?

This clinical trial studies the following conditions: Hypercholesterolemia.

What interventions are being tested in trial NCT01954394?

The interventions under investigation include: Alirocumab (DRUG), Lipid-Modifying Therapy (LMT) (DRUG).

Who is sponsoring clinical trial NCT01954394?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01954394 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.