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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 is a Phase 2 study that has completed, run by Amgen. The registered enrollment target is 411 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01375777
The ClinicalTrials.gov registry entry for NCT01375777 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 411 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Ezetimibe is the first listed.
NCT01375777 reports 0 study locations.
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.
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