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An Exploratory Sub-study for the RED-HF™ (Reduction of Events With Darbepoetin Alfa in Heart Failure) Trial

NCT00534456 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2011-04-08

No results posted yet for this study

Summary

The purpose of Study 20060172 was to measure echocardiographic parameters and biomarkers in a subgroup of study subjects enrolled in Study 20050222 (the RED-HF Trial). This substudy 20060172 was terminated early due to feasibility constraints. All subjects enrolled in 20060172 were also enrolled in Study 20050222, which is ongoing. Study data will be analyzed when Study 20050222 ends, since unblinding before then would adversely affect Study 20050222.

Conditions

Interventions

DRUG

Placebo

Placebo group to receive volume and dose frequency changes resembling titration dosing in the treatment group.

DRUG

Darbepoetin alfa

Starting dose: 0.75 mcg/kg subcutaneously Q2W. Subsequent doses: Darbepoetin alfa group to receive darbepoetin alfa titrated to achieve Hb target of 13.0 g/dL, not to exceed 14.5 g/dL.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2007-10-31
Completion
2007-10-31

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Entities

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00534456 on ClinicalTrials.gov