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NCT02833844 · ClinicalTrials.gov registry record · Phase 3
Safety, Tolerability and Efficacy on Low Density Lipoprotein Cholesterol (LDL-C) of Evolocumab in Participants With Human Immunodeficiency Virus (HIV) and Hyperlipidemia/Mixed Dyslipidemia
A Phase 3 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 467
- Enrollment target
NCT02833844 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 467 participants.
The verdict
NCT02833844, a Phase 3 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 467 participants
- Enrollment target
Study Summary
The study is divided into 2 parts. The first part of the study will be double-blinded and will last for 24 weeks. During this time, participants will be randomized in a ratio of 2:1 to receive either evolocumab once monthly (QM) or placebo QM. The second part of the study is a 24-week open label extension period. During this time all participants will receive evolocumab QM. The clinical hypothesis is that subcutaneous evolocumab QM will be well tolerated and will result in greater reduction of low density lipoprotein cholesterol (LDL-C), defined as percent change from baseline at Week 24, compared with placebo QM in human immunodeficiency virus (HIV)-positive participants with hyperlipidemia or mixed dyslipidemia.
Interventions
- DRUG Placebo
- DRUG Evolocumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 467 participants |
| Start Date | 2017-05-22 |
| Est. Completion | 2020-01-27 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02833844
The ClinicalTrials.gov registry entry for NCT02833844 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 467 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 2 interventions - of which Placebo is the first listed.
NCT02833844 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02833844 about?
NCT02833844 is a clinical study titled "Safety, Tolerability and Efficacy on Low Density Lipoprotein Cholesterol (LDL-C) of Evolocumab in Participants With Human Immunodeficiency Virus (HIV) and Hyperlipidemia/Mixed Dyslipidemia". The study is divided into 2 parts. The first part of the study will be double-blinded and will last for 24 weeks. During this time, participants will be randomized in a ratio of 2:1 to receive either evolocumab once monthly (QM) or placebo QM. The second part of the study is a 24-week open label ext...
What is the current status of trial NCT02833844?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 467 participants. The study started on 2017-05-22. Estimated completion is 2020-01-27.
What interventions are being tested in trial NCT02833844?
The interventions under investigation include: Placebo (DRUG), Evolocumab (DRUG).
Who is sponsoring clinical trial NCT02833844?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
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