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NCT01984424 · ClinicalTrials.gov registry record · Phase 3
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3
A Phase 3 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 511
- Enrollment target
NCT01984424 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 511 participants.
The verdict
NCT01984424, a Phase 3 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 511 participants
- Enrollment target
Study Summary
The primary objective of this study was to evaluate the effect of 24 weeks of evolocumab administered subcutaneously (SC) every month, compared with ezetimibe, on low-density lipoprotein cholesterol (LDL-C) levels in adults with high cholesterol who are unable to tolerate an effective dose of a statin due to muscle-related side effects (MRSE).
Interventions
- DRUG Ezetimibe
- DRUG Atorvastatin
- OTHER Placebo to Evolocumab
- DRUG Placebo to Atorvastatin
- OTHER Placebo to Ezetimibe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 511 participants |
| Start Date | 2013-12-10 |
| Est. Completion | 2017-11-21 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01984424
The ClinicalTrials.gov registry entry for NCT01984424 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 511 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.
NCT01984424 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01984424 about?
NCT01984424 is a clinical study titled "Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3". The primary objective of this study was to evaluate the effect of 24 weeks of evolocumab administered subcutaneously (SC) every month, compared with ezetimibe, on low-density lipoprotein cholesterol (LDL-C) levels in adults with high cholesterol who are unable to tolerate an effective dose of a stat...
What is the current status of trial NCT01984424?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 511 participants. The study started on 2013-12-10. Estimated completion is 2017-11-21.
What interventions are being tested in trial NCT01984424?
The interventions under investigation include: Ezetimibe (DRUG), Atorvastatin (DRUG), Placebo to Evolocumab (OTHER), Placebo to Atorvastatin (DRUG), Placebo to Ezetimibe (OTHER).
Who is sponsoring clinical trial NCT01984424?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
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