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NCT01763827 · ClinicalTrials.gov registry record · Phase 3
Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing Lipid Levels-2
A Phase 3 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 615
- Enrollment target
NCT01763827 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 615 participants.
The verdict
NCT01763827, a Phase 3 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 615 participants
- Enrollment target
Study Summary
The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneous (SC) monotherapy every 2 weeks (Q2W) and monthly (QM), compared with placebo and ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in adults with a 10-year Framingham risk score of 10% or less.
Interventions
- DRUG Ezetimibe
- BIOLOGICAL Evolocumab
- OTHER Placebo to Ezetimibe
- BIOLOGICAL Placebo to Evolocumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 615 participants |
| Start Date | 2013-01-21 |
| Est. Completion | 2013-10-29 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01763827
The ClinicalTrials.gov registry entry for NCT01763827 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 615 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 4 interventions - of which Ezetimibe is the first listed.
NCT01763827 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01763827 about?
NCT01763827 is a clinical study titled "Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing Lipid Levels-2". The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneous (SC) monotherapy every 2 weeks (Q2W) and monthly (QM), compared with placebo and ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in adults with a 10-year Framingham risk ...
What is the current status of trial NCT01763827?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 615 participants. The study started on 2013-01-21. Estimated completion is 2013-10-29.
What interventions are being tested in trial NCT01763827?
The interventions under investigation include: Ezetimibe (DRUG), Evolocumab (BIOLOGICAL), Placebo to Ezetimibe (OTHER), Placebo to Evolocumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01763827?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
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