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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 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 683 participants.

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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

FieldValue
Enrollment Target 683 participants
Start Date 2013-08-13
Est. Completion 2015-01-08
Phase Phase 3

Sponsor

Amgen

558 total trials

What the Registry Record Tells You About NCT01896232

The ClinicalTrials.gov registry entry for NCT01896232 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 683 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 4 interventions - of which Oral Placebo is the first listed.

NCT01896232 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.