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NCT01788046 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis
A Phase 3 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 515
- Enrollment target
NCT01788046 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 515 participants.
The verdict
NCT01788046, a Phase 3 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 515 participants
- Enrollment target
Study Summary
This study is designed to assess the efficacy and safety of etelcalcetide (AMG 416) compared with placebo in the treatment of SHPT in CKD patients receiving hemodialysis.
Interventions
- DRUG Placebo
- DRUG Etelcalcetide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 515 participants |
| Start Date | 2013-03-12 |
| Est. Completion | 2014-05-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01788046
The ClinicalTrials.gov registry entry for NCT01788046 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 515 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.
NCT01788046 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01788046 about?
NCT01788046 is a clinical study titled "Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis". This study is designed to assess the efficacy and safety of etelcalcetide (AMG 416) compared with placebo in the treatment of SHPT in CKD patients receiving hemodialysis.
What is the current status of trial NCT01788046?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 515 participants. The study started on 2013-03-12. Estimated completion is 2014-05-09.
What interventions are being tested in trial NCT01788046?
The interventions under investigation include: Placebo (DRUG), Etelcalcetide (DRUG).
Who is sponsoring clinical trial NCT01788046?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
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