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NCT00358215 · ClinicalTrials.gov registry record · Phase 3

RED-HF™ Trial - Reduction of Events With Darbepoetin Alfa in Heart Failure Trial

A Phase 3 study, sponsored by Amgen.

Completed
Registry status
Phase 3
Development phase
2,278
Enrollment target

NCT00358215: Completed Phase 3 study, sponsored by Amgen.

NCT00358215 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 2,278 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (195% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00358215, a Phase 3 study, has completed, sponsored by Amgen.

COMPLETED
Registry status
Phase 3
Development phase
2,278 participants
Enrollment target

Study Summary

The purpose of the study is to determine the efficacy of treatment of anemia with darbepoetin alfa compared to placebo on the composite of time to death from any cause or first hospital admission for worsening heart failure in patients with symptomatic left ventricular systolic dysfunction and anemia.

Primary Outcome

Time to death from any cause or first hospital admission for worsening heart failure (adjudicated by the Clinical Endpoint Committee), whichever occurred first, estimated by Kaplan-Meier method. Participants not experiencing a qualifying event during the study were censored at their last contact time or the study termination date, whichever occurred first.

Interventions

  • DRUG Placebo
  • DRUG Darbepoetin alfa

Trial Details

FieldValue
Enrollment Target 2,278 participants
Start Date 2006-06-01
Est. Completion 2012-10-11
Phase Phase 3
Amgen

558 total trials

What the finished NCT00358215 record still lists

NCT00358215 is an interventional study that assigns participants to a tested intervention. Its 2,278 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (195% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00358215 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00358215 about?

NCT00358215 is a clinical study titled "RED-HF™ Trial - Reduction of Events With Darbepoetin Alfa in Heart Failure Trial". The purpose of the study is to determine the efficacy of treatment of anemia with darbepoetin alfa compared to placebo on the composite of time to death from any cause or first hospital admission for worsening heart failure in patients with symptomatic left ventricular systolic dysfunction and anemi...

What is the current status of trial NCT00358215?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,278 participants. The study started on 2006-06-01. Estimated completion is 2012-10-11.

What interventions are being tested in trial NCT00358215?

The interventions under investigation include: Placebo (DRUG), Darbepoetin alfa (DRUG).

Who is sponsoring clinical trial NCT00358215?

This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00358215's enrollment target sits among peer trials

2,278 94th of 2000 higher than 1,907 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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Source: ClinicalTrials.gov NCT00358215, the US trial registry maintained by the National Library of Medicine. NCT00358215 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.