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NCT01375777 · ClinicalTrials.gov registry record · Phase 2
Monoclonal Antibody Against PCSK9 to Reduce Elevated Low-density Lipoprotein Cholesterol (LDL-C) in Adults Currently Not Receiving Drug Therapy for Easing Lipid Levels
A Phase 2 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 2
- Development phase
- 411
- Enrollment target
NCT01375777: Completed Phase 2 study, sponsored by Amgen.
NCT01375777 is a Phase 2 study that has completed, run by Amgen. The registered enrollment target is 411 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (209% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01375777, a Phase 2 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 411 participants
- Enrollment target
Study Summary
The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145) every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on the percent change from baseline in LDL-C when used as monotherapy in adults with hypercholesterolemia.
Primary Outcome
LDL-C was measured using ultracentrifugation.
Interventions
- DRUG Ezetimibe
- BIOLOGICAL Evolocumab
- OTHER Placebo to Evolocumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 411 participants |
| Start Date | 2011-07-06 |
| Est. Completion | 2012-03-02 |
| Phase | Phase 2 |
What the finished NCT01375777 record still lists
NCT01375777 is an interventional study that assigns participants to a tested intervention. The registered 411 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (209% higher).
The record links to 0 conditions, and to 3 interventions - of which Ezetimibe is the first listed.
NCT01375777 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01375777 about?
NCT01375777 is a clinical study titled "Monoclonal Antibody Against PCSK9 to Reduce Elevated Low-density Lipoprotein Cholesterol (LDL-C) in Adults Currently Not Receiving Drug Therapy for Easing Lipid Levels". The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145) every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on the percent change from baseline in LDL-C when used as monotherapy in adults with hypercholesterolemia.
What is the current status of trial NCT01375777?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 411 participants. The study started on 2011-07-06. Estimated completion is 2012-03-02.
What interventions are being tested in trial NCT01375777?
The interventions under investigation include: Ezetimibe (DRUG), Evolocumab (BIOLOGICAL), Placebo to Evolocumab (OTHER).
Who is sponsoring clinical trial NCT01375777?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01375777's enrollment target sits among peer trials
411 93rd of 2000 higher than 1,908 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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