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NCT01763866 · ClinicalTrials.gov registry record · Phase 3
LDL-C Assessment With PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy-2
A Phase 3 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,067
- Enrollment target
NCT01763866 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 2,067 participants.
The verdict
NCT01763866, a Phase 3 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,067 participants
- Enrollment target
Study Summary
The primary objective was to evaluate the effect of 12 weeks of evolocumab administered subcutaneously every 2 weeks (Q2W) and monthly (QM) when used in combination with a statin, compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia.
Interventions
- DRUG Ezetimibe
- DRUG Atorvastatin
- BIOLOGICAL Evolocumab
- DRUG Placebo to Evolocumab
- DRUG Placebo to Ezetimibe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,067 participants |
| Start Date | 2013-01-15 |
| Est. Completion | 2013-12-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01763866
The ClinicalTrials.gov registry entry for NCT01763866 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 2,067 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 5 interventions - of which Ezetimibe is the first listed.
NCT01763866 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01763866 about?
NCT01763866 is a clinical study titled "LDL-C Assessment With PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy-2". The primary objective was to evaluate the effect of 12 weeks of evolocumab administered subcutaneously every 2 weeks (Q2W) and monthly (QM) when used in combination with a statin, compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients with p...
What is the current status of trial NCT01763866?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,067 participants. The study started on 2013-01-15. Estimated completion is 2013-12-04.
What interventions are being tested in trial NCT01763866?
The interventions under investigation include: Ezetimibe (DRUG), Atorvastatin (DRUG), Evolocumab (BIOLOGICAL), Placebo to Evolocumab (DRUG), Placebo to Ezetimibe (DRUG).
Who is sponsoring clinical trial NCT01763866?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
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