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NCT01763918 · ClinicalTrials.gov registry record · Phase 3
Reduction of LDL-C With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study-2
A Phase 3 study of Hyperlipidemia, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 331
- Enrollment target
- 20
- Study locations
NCT01763918: Completed Phase 3 study of Hyperlipidemia, sponsored by Amgen.
NCT01763918 is a Phase 3 study of Hyperlipidemia that has completed, run by Amgen. The registered enrollment target is 331 participants, below the 398-participant average among 35 other Hyperlipidemia trials with a reported enrollment target (17% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01763918, a Phase 3 study of Hyperlipidemia, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 331 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneously once every 2 weeks (Q2W) and once monthly (QM), compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in adults with heterozygous familial hypercholesterolemia (HeFH).
Conditions Studied
Interventions
- DRUG Placebo
- BIOLOGICAL Evolocumab
Study Locations (20)
Other
- Research Site - Bron
- Research Site - Nantes
- Research Site - Paris
- Research Site - Cologne
- Research Site - New Territories
- Research Site - Amersfoort
- Research Site - Amsterdam
- Research Site - Amsterdam
- Research Site - Gouda
- Research Site - Groningen
- Research Site - Hoorn
Quebec
- Research Site - Chicoutimi
- Research Site - Montreal
- Research Site - Montreal
Arizona
- Research Site - Scottsdale
Ohio
- Research Site - Cincinnati
New South Wales
- Research Site - Camperdown
Western Australia
- Research Site - Perth
British Columbia
- Research Site - Vancouver
Ontario
- Research Site - London
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 331 participants |
| Start Date | 2013-02-07 |
| Est. Completion | 2013-12-19 |
| Phase | Phase 3 |
What the finished NCT01763918 record still lists
NCT01763918 is an interventional study that assigns participants to a tested intervention. The registered 331 participants enrollment target is mid-sized for trials with a published cap, below the 398-participant average among 35 other Hyperlipidemia trials with a reported enrollment target (17% lower).
The record links to 1 condition, with Hyperlipidemia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01763918 names 20 study sites across 8 states, led by Other, Quebec, Arizona.
Frequently Asked Questions
What is clinical trial NCT01763918 about?
NCT01763918 is a clinical study titled "Reduction of LDL-C With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study-2". The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneously once every 2 weeks (Q2W) and once monthly (QM), compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in adults with heterozygous familial hypercholesterolemia (H...
What is the current status of trial NCT01763918?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 331 participants. The study started on 2013-02-07. Estimated completion is 2013-12-19.
What conditions does trial NCT01763918 study?
This clinical trial studies the following conditions: Hyperlipidemia.
What interventions are being tested in trial NCT01763918?
The interventions under investigation include: Placebo (DRUG), Evolocumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01763918?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01763918 being conducted?
This trial has 20 study locations across Arizona, Ohio, New South Wales, Western Australia, British Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT01763918's enrollment target sits among peer trials
331 9th of 35 higher than 27 of 35 other Hyperlipidemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hyperlipidemia 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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