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NCT01576484 · ClinicalTrials.gov registry record · Phase 2
Open-Label Extension of Study R727-CL-1003 (NCT01266876) to Evaluate the Long-Term Safety and Efficacy of Alirocumab (REGN727) in Participants With Heterozygous Familial Hypercholesterolemia (HeFH)
A Phase 2 study of Hypercholesterolemia and Heterozygous Familial Hypercholesterolemia, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 58
- Enrollment target
- 14
- Study locations
NCT01576484: Completed Phase 2 study of Hypercholesterolemia and Heterozygous Familial Hypercholesterolemia, sponsored by Regeneron Pharmaceuticals.
NCT01576484 is a Phase 2 study of Hypercholesterolemia and Heterozygous Familial Hypercholesterolemia that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 58 participants, below the 816-participant average among 62 other Hypercholesterolemia trials with a reported enrollment target (93% lower). The trial reports 14 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01576484, a Phase 2 study of Hypercholesterolemia and Heterozygous Familial Hypercholesterolemia, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 58 participants
- Enrollment target
- 14
- Study locations
Study Summary
The primary objective of the study was to assess the long-term safety and tolerability of alirocumab in patients with heFH who were receiving concomitant treatment with hydroxymethyl glutaryl-coenzyme A (HMG-CoA) reductase inhibitors (statins), with or without other lipid-modifying therapies (LMTs).
Primary Outcome
An AE was defined as any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. Treatment- emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on- treatment period (time from the first dose of study drug to the last dose of study drug plus 70 days). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the followin
Conditions Studied
Interventions
- DRUG Alirocumab
- DRUG Placebo Matched to Alirocumab
Study Locations (14)
California
- - Mission Viejo
- - Newport Beach
- - Thousand Oaks
Quebec
- - Chicoutimi
- - Montreal
- - Sainte-Foy
Florida
- - Miami
- - Port Orange
Kansas
- - Kansas City
Maine
- - Auburn
Missouri
- - St Louis
North Carolina
- - Durham
Ohio
- - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2012-02-28 |
| Est. Completion | 2016-12-22 |
| Phase | Phase 2 |
What the finished NCT01576484 record still lists
NCT01576484 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 816-participant average among 62 other Hypercholesterolemia trials with a reported enrollment target (93% lower).
The record links to 2 conditions, with Hypercholesterolemia appearing as the primary indexed condition, and to 2 interventions - of which Alirocumab is the first listed.
NCT01576484 lists 14 locations in 9 states (California, Quebec, Florida).
Frequently Asked Questions
What is clinical trial NCT01576484 about?
NCT01576484 is a clinical study titled "Open-Label Extension of Study R727-CL-1003 (NCT01266876) to Evaluate the Long-Term Safety and Efficacy of Alirocumab (REGN727) in Participants With Heterozygous Familial Hypercholesterolemia (HeFH)". The primary objective of the study was to assess the long-term safety and tolerability of alirocumab in patients with heFH who were receiving concomitant treatment with hydroxymethyl glutaryl-coenzyme A (HMG-CoA) reductase inhibitors (statins), with or without other lipid-modifying therapies (LMTs).
What is the current status of trial NCT01576484?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 58 participants. The study started on 2012-02-28. Estimated completion is 2016-12-22.
What conditions does trial NCT01576484 study?
This clinical trial studies the following conditions: Hypercholesterolemia, Heterozygous Familial Hypercholesterolemia.
What interventions are being tested in trial NCT01576484?
The interventions under investigation include: Alirocumab (DRUG), Placebo Matched to Alirocumab (DRUG).
Who is sponsoring clinical trial NCT01576484?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01576484 being conducted?
This trial has 14 study locations across California, Florida, Kansas, Maine, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01576484's enrollment target sits among peer trials
58 52nd of 62 higher than 11 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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