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NCT01896232 · ClinicalTrials.gov registry record · Phase 3
Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet
A Phase 3 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 683
- Enrollment target
NCT01896232: Completed Phase 3 study, sponsored by Amgen.
NCT01896232 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 683 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (12% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01896232, a Phase 3 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 683 participants
- Enrollment target
Study Summary
The purpose of this study is to demonstrate that treatment with etelcalcetide (AMG 416) is not inferior to treatment with cinacalcet for lowering serum parathyroid hormone (PTH) levels by \> 30% from baseline among patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT) who require management with hemodialysis.
Interventions
- DRUG Oral Placebo
- DRUG Intravenous Placebo
- DRUG Etelcalcetide
- DRUG Cinacalcet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 683 participants |
| Start Date | 2013-08-13 |
| Est. Completion | 2015-01-08 |
| Phase | Phase 3 |
What the finished NCT01896232 record still lists
NCT01896232 is an interventional study that assigns participants to a tested intervention. The registered 683 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (12% lower).
The record links to 0 conditions, and to 4 interventions - of which Oral Placebo is the first listed.
NCT01896232 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01896232 about?
NCT01896232 is a clinical study titled "Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet". The purpose of this study is to demonstrate that treatment with etelcalcetide (AMG 416) is not inferior to treatment with cinacalcet for lowering serum parathyroid hormone (PTH) levels by \> 30% from baseline among patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT) w...
What is the current status of trial NCT01896232?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 683 participants. The study started on 2013-08-13. Estimated completion is 2015-01-08.
What interventions are being tested in trial NCT01896232?
The interventions under investigation include: Oral Placebo (DRUG), Intravenous Placebo (DRUG), Etelcalcetide (DRUG), Cinacalcet (DRUG).
Who is sponsoring clinical trial NCT01896232?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01896232's enrollment target sits among peer trials
683 529th of 2000 higher than 1,472 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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