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NCT01576484 · ClinicalTrials.gov registry record · Phase 2

Open-Label Extension of Study R727-CL-1003 (NCT01266876) to Evaluate the Long-Term Safety and Efficacy of Alirocumab (REGN727) in Participants With Heterozygous Familial Hypercholesterolemia (HeFH)

A Phase 2 study of Hypercholesterolemia and Heterozygous Familial Hypercholesterolemia, sponsored by Regeneron Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
58
Enrollment target
14
Study locations

NCT01576484 is a Phase 2 study of Hypercholesterolemia and Heterozygous Familial Hypercholesterolemia that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 58 participants, below the 816-participant average among 62 other Hypercholesterolemia trials with a reported enrollment target (93% lower). The trial reports 14 study locations across 9 states.

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The verdict

NCT01576484, a Phase 2 study of Hypercholesterolemia and Heterozygous Familial Hypercholesterolemia, has completed, sponsored by Regeneron Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
58 participants
Enrollment target
14
Study locations

Study Summary

The primary objective of the study was to assess the long-term safety and tolerability of alirocumab in patients with heFH who were receiving concomitant treatment with hydroxymethyl glutaryl-coenzyme A (HMG-CoA) reductase inhibitors (statins), with or without other lipid-modifying therapies (LMTs).

Conditions Studied

Hypercholesterolemia Heterozygous Familial Hypercholesterolemia

Interventions

  • DRUG Alirocumab
  • DRUG Placebo Matched to Alirocumab

Study Locations (14)

California

  • - Mission Viejo
  • - Newport Beach
  • - Thousand Oaks

Quebec

  • - Chicoutimi
  • - Montreal
  • - Sainte-Foy

Florida

  • - Miami
  • - Port Orange

Kansas

  • - Kansas City

Maine

  • - Auburn

Missouri

  • - St Louis

North Carolina

  • - Durham

Ohio

  • - Cincinnati

Trial Details

FieldValue
Enrollment Target 58 participants
Start Date 2012-02-28
Est. Completion 2016-12-22
Phase Phase 2

Sponsor

Regeneron Pharmaceuticals

280 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01576484

The ClinicalTrials.gov registry entry for NCT01576484 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 58 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 816-participant average among 62 other Hypercholesterolemia trials with a reported enrollment target (93% lower). The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.

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

NCT01576484 reports 14 study locations spanning 9 distinct geographic areas - top geographies include California, Quebec, Florida.

Frequently Asked Questions

What is clinical trial NCT01576484 about?

NCT01576484 is a clinical study titled "Open-Label Extension of Study R727-CL-1003 (NCT01266876) to Evaluate the Long-Term Safety and Efficacy of Alirocumab (REGN727) in Participants With Heterozygous Familial Hypercholesterolemia (HeFH)". The primary objective of the study was to assess the long-term safety and tolerability of alirocumab in patients with heFH who were receiving concomitant treatment with hydroxymethyl glutaryl-coenzyme A (HMG-CoA) reductase inhibitors (statins), with or without other lipid-modifying therapies (LMTs).

What is the current status of trial NCT01576484?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 58 participants. The study started on 2012-02-28. Estimated completion is 2016-12-22.

What conditions does trial NCT01576484 study?

This clinical trial studies the following conditions: Hypercholesterolemia, Heterozygous Familial Hypercholesterolemia.

What interventions are being tested in trial NCT01576484?

The interventions under investigation include: Alirocumab (DRUG), Placebo Matched to Alirocumab (DRUG).

Who is sponsoring clinical trial NCT01576484?

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

Where is trial NCT01576484 being conducted?

This trial has 14 study locations across California, Florida, Kansas, Maine, Missouri. 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.