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NCT02211209 · ClinicalTrials.gov registry record · Phase 3

The APPROACH Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Patients With Familial Chylomicronemia Syndrome

A Phase 3 study of Familial Chylomicronemia Syndrome, sponsored by Ionis Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
67
Enrollment target
20
Study locations

NCT02211209 is a Phase 3 study of Familial Chylomicronemia Syndrome that has completed, run by Ionis Pharmaceuticals. The registered enrollment target is 67 participants, roughly in line with the 65-participant average among 4 other Familial Chylomicronemia Syndrome trials with a reported enrollment target. The trial reports 20 study locations across 13 states.

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The verdict

NCT02211209, a Phase 3 study of Familial Chylomicronemia Syndrome, has completed, sponsored by Ionis Pharmaceuticals.

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

Study Summary

The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 52 weeks in participants with Familial Chylomicronemia Syndrome

Conditions Studied

Familial Chylomicronemia Syndrome

Interventions

  • DRUG Placebo
  • DRUG Volanesorsen

Study Locations (20)

Other

  • IONIS Investigative Site - Campinas
  • IONIS Investigative Site - São Paulo
  • IONIS Investigative Site - São Paulo
  • IONIS Investigative Site - Marseille
  • IONIS Investigative Site - Nantes
  • IONIS Investigative Site - Paris

California

  • IONIS Investigative Site - Encinitas
  • IONIS Investigative Site - San Francisco

Quebec

  • IONIS Investigative Site - Chicoutimi
  • IONIS Investigative Site - Sainte-Foy

Kansas

  • IONIS Investigative Site - Kansas City

Massachusetts

  • IONIS Investigative Site - Boston

New York

  • IONIS Investigative Site - New York

Oklahoma

  • IONIS Investigative Site - Oklahoma City

Oregon

  • IONIS Investigative Site - Portland

Trial Details

FieldValue
Enrollment Target 67 participants
Start Date 2014-12
Est. Completion 2017-03-28
Phase Phase 3

Sponsor

Ionis Pharmaceuticals

76 total trials

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What the Registry Record Tells You About NCT02211209

The ClinicalTrials.gov registry entry for NCT02211209 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 67 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 65-participant average among 4 other Familial Chylomicronemia Syndrome trials with a reported enrollment target. The listed sponsor is Ionis Pharmaceuticals, which has 76 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Familial Chylomicronemia Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT02211209 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Other, California, Quebec.

Frequently Asked Questions

What is clinical trial NCT02211209 about?

NCT02211209 is a clinical study titled "The APPROACH Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Patients With Familial Chylomicronemia Syndrome". The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 52 weeks in participants with Familial Chylomicronemia Syndrome

What is the current status of trial NCT02211209?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 67 participants. The study started on 2014-12. Estimated completion is 2017-03-28.

What conditions does trial NCT02211209 study?

This clinical trial studies the following conditions: Familial Chylomicronemia Syndrome.

What interventions are being tested in trial NCT02211209?

The interventions under investigation include: Placebo (DRUG), Volanesorsen (DRUG).

Who is sponsoring clinical trial NCT02211209?

This trial is sponsored by Ionis Pharmaceuticals, which has 76 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02211209 being conducted?

This trial has 20 study locations across California, Kansas, Massachusetts, New York, Oklahoma. 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.