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NCT01954394 · ClinicalTrials.gov registry record · Phase 3
Open Label Study of Long Term Safety Evaluation of Alirocumab
A Phase 3 study of Hypercholesterolemia, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 986
- Enrollment target
- 20
- Study locations
NCT01954394: Completed Phase 3 study of Hypercholesterolemia, sponsored by Sanofi.
NCT01954394 is a Phase 3 study of Hypercholesterolemia that has completed, run by Sanofi. The registered enrollment target is 986 participants, above the 801-participant average among 62 other Hypercholesterolemia trials with a reported enrollment target (23% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01954394, a Phase 3 study of Hypercholesterolemia, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 986 participants
- Enrollment target
- 20
- Study locations
Study Summary
Primary Objective: To assess the long-term safety of alirocumab (SAR236553/REGN727) when added to lipid-lowering therapy in participants with heterozygous familial hypercholesterolemia (heFH) who had completed EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500), EFC12732 (NCT01617655) and LTS11717 (NCT01507831). Secondary Objectives: * To evaluate the long-term efficacy of alirocumab on lipid parameters. * To evaluate the long-term immunogenicity of alirocumab.
Primary Outcome
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study +70 days). Clinically significant lab and vital sign abnormalities were to be reported as AEs.
Conditions Studied
Interventions
- DRUG Alirocumab
- DRUG Lipid-Modifying Therapy (LMT)
Study Locations (20)
Florida
- Investigational Site Number 840344 - Atlantis
- Investigational Site Number 840353 - Clearwater
- Investigational Site Number 840318 - Fort Lauderdale
- Investigational Site Number 840327 - Jacksonville
- Investigational Site Number 840309 - Miami
- Investigational Site Number 840351 - Sarasota
California
- Investigational Site Number 840334 - Bell Gardens
- Investigational Site Number 840319 - Fountain Valley
- Investigational Site Number 840336 - Los Angeles
- Investigational Site Number 840339 - Mission Viejo
- Investigational Site Number 840337 - Newport Beach
Illinois
- Investigational Site Number 840315 - Evanston
- Investigational Site Number 840305 - Oakbrook Terrace
Alabama
- Investigational Site Number 840321 - Huntsville
Arizona
- Investigational Site Number 840341 - Tempe
Colorado
- Investigational Site Number 840306 - Golden
District of Columbia
- Investigational Site Number 840328 - Washington D.C.
Iowa
- Investigational Site Number 840333 - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 986 participants |
| Start Date | 2013-12-17 |
| Est. Completion | 2017-06-30 |
| Phase | Phase 3 |
What the finished NCT01954394 record still lists
NCT01954394 is an interventional study that assigns participants to a tested intervention. The registered 986 participants enrollment target is mid-sized for trials with a published cap, above the 801-participant average among 62 other Hypercholesterolemia trials with a reported enrollment target (23% higher).
The record links to 1 condition, with Hypercholesterolemia appearing as the primary indexed condition, and to 2 interventions - of which Alirocumab is the first listed.
NCT01954394 names 20 study sites across 10 states, led by Florida, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT01954394 about?
NCT01954394 is a clinical study titled "Open Label Study of Long Term Safety Evaluation of Alirocumab". Primary Objective: To assess the long-term safety of alirocumab (SAR236553/REGN727) when added to lipid-lowering therapy in participants with heterozygous familial hypercholesterolemia (heFH) who had completed EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500), EFC12732 (NCT01617655) and LTS11717 (...
What is the current status of trial NCT01954394?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 986 participants. The study started on 2013-12-17. Estimated completion is 2017-06-30.
What conditions does trial NCT01954394 study?
This clinical trial studies the following conditions: Hypercholesterolemia.
What interventions are being tested in trial NCT01954394?
The interventions under investigation include: Alirocumab (DRUG), Lipid-Modifying Therapy (LMT) (DRUG).
Who is sponsoring clinical trial NCT01954394?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01954394 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hypercholesterolemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01954394's enrollment target sits among peer trials
986 11th of 62 higher than 52 of 62 other Hypercholesterolemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypercholesterolemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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