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NCT02326220 · ClinicalTrials.gov registry record · Phase 3
Study of Alirocumab (REGN727/SAR236553) in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) Undergoing Low-density Lipoprotein (LDL) Apheresis Therapy
A Phase 3 study of Heterozygous Familial Hypercholesterolemia, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 62
- Enrollment target
- 13
- Study locations
NCT02326220: Completed Phase 3 study of Heterozygous Familial Hypercholesterolemia, sponsored by Regeneron Pharmaceuticals.
NCT02326220 is a Phase 3 study of Heterozygous Familial Hypercholesterolemia that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 62 participants, below the 248-participant average among 4 other Heterozygous Familial Hypercholesterolemia trials with a reported enrollment target (75% lower). The trial reports 13 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02326220, a Phase 3 study of Heterozygous Familial Hypercholesterolemia, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 62 participants
- Enrollment target
- 13
- Study locations
Study Summary
The primary objective of the study is to evaluate the effect of alirocumab 150 mg every 2 weeks (Q2W) in comparison with placebo on the frequency of low-density lipoprotein (LDL) apheresis treatments in participants with heterozygous familial hypercholesterolemia (HeFH) undergoing weekly or bi-weekly LDL apheresis therapy.
Primary Outcome
Rate of apheresis treatments were normalized by the number of planned apheresis treatments according to each participant's established schedule at screening, week -10 to week -2. The normalized rate of apheresis was defined for each participant as the number of actual apheresis treatments received from week 7 to week 18 divided by the number of planned apheresis treatments per randomization strata at baseline (6 for Q2W and 12 for QW).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Alirocumab
Study Locations (13)
Other
- - Berlin
- - Göttingen
- - Muenchen (2 Locations)
- - Passau
- - Rostock
Colorado
- - Aurora
Connecticut
- - Hartford
Kansas
- - Kansas City
Maine
- - Scarborough
Minnesota
- - Rochester
Oregon
- - Portland
Pennsylvania
- - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2015-03-31 |
| Est. Completion | 2016-04-30 |
| Phase | Phase 3 |
What the finished NCT02326220 record still lists
NCT02326220 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 248-participant average among 4 other Heterozygous Familial Hypercholesterolemia trials with a reported enrollment target (75% lower).
The record links to 1 condition, with Heterozygous Familial Hypercholesterolemia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02326220 lists 13 locations in 9 states (Other, Colorado, Connecticut).
Frequently Asked Questions
What is clinical trial NCT02326220 about?
NCT02326220 is a clinical study titled "Study of Alirocumab (REGN727/SAR236553) in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) Undergoing Low-density Lipoprotein (LDL) Apheresis Therapy". The primary objective of the study is to evaluate the effect of alirocumab 150 mg every 2 weeks (Q2W) in comparison with placebo on the frequency of low-density lipoprotein (LDL) apheresis treatments in participants with heterozygous familial hypercholesterolemia (HeFH) undergoing weekly or bi-weekl...
What is the current status of trial NCT02326220?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 62 participants. The study started on 2015-03-31. Estimated completion is 2016-04-30.
What conditions does trial NCT02326220 study?
This clinical trial studies the following conditions: Heterozygous Familial Hypercholesterolemia.
What interventions are being tested in trial NCT02326220?
The interventions under investigation include: Placebo (DRUG), Alirocumab (DRUG).
Who is sponsoring clinical trial NCT02326220?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02326220 being conducted?
This trial has 13 study locations across Colorado, Connecticut, Kansas, Maine, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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