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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: Completed Phase 3 study of Familial Chylomicronemia Syndrome, sponsored by Ionis Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
The Month 3 endpoint was defined as the average of Week 12 (Day 78) and Week 13 (Day 85) fasting assessments.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2014-12 |
| Est. Completion | 2017-03-28 |
| Phase | Phase 3 |
What the finished NCT02211209 record still lists
NCT02211209 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, roughly in line with the 65-participant average among 4 other Familial Chylomicronemia Syndrome trials with a reported enrollment target.
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 names 20 study sites across 13 states, led by 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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