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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT02211209

Public ClinicalTrials.gov record NCT02211209. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 22, 2026, 10:41 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of ISIS 304801 Administered Subcutaneously to Patients With Familial Chylomicronemia Syndrome (FCS)

Study identification

NCT ID
NCT02211209
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Ionis Pharmaceuticals, Inc.
Industry
Enrollment
67 participants

Conditions and interventions

Interventions

  • Volanesorsen Drug
  • Placebo Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 30, 2014
Primary completion
Dec 18, 2016
Completion
Mar 27, 2017
Last update posted
Apr 12, 2022

2014 – 2017

United States locations

U.S. sites
11
U.S. states
10
U.S. cities
11
Facility City State ZIP Site status
IONIS Investigative Site Encinitas California 92024
IONIS Investigative Site San Francisco California 94143
IONIS Investigative Site Kansas City Kansas 66214
IONIS Investigative Site Boston Massachusetts 02114
IONIS Investigative Site New York New York 10016
IONIS Investigative Site Oklahoma City Oklahoma 73103
IONIS Investigative Site Portland Oregon 97239
IONIS Investigative Site Philadelphia Pennsylvania 19104
IONIS Investigative Site Houston Texas 77030
IONIS Investigative Site Norfolk Virginia 23510
IONIS Investigative Site Seattle Washington 98104

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 29 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02211209, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 12, 2022 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02211209 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →