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COMPLETED 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)

NCT01576484 · View on ClinicalTrials.gov ↗

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).

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

290 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. 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 58 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 290 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. 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: NCT01576484 reports 14 study locations spanning 9 distinct geographic areas — top geographies include California, Quebec, Florida. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01576484?

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

Who is sponsoring clinical trial NCT01576484?

This trial is sponsored by Regeneron Pharmaceuticals, which has 290 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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