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A Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy

NCT00118638 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 705

Last updated 2013-04-29

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy of darbepoetin alfa as 500ug once every 3 weeks to show that the dose and schedule are not inferior to darbepoetin alfa administered as 2.25ug/kg once per week in the treatment of anemia in subjects with non-myeloid malignancies.

Conditions

  • Anemia
  • Non-Myeloid Malignancies

Interventions

DRUG

Darbepoetin alfa - 2.25 mcg/kg

Darbepoetin alfa 2.25 mcg/kg QW dosing/ placebo Q3W

DRUG

Darbepoetin alfa - 500mcg

Darbepoetin alfa 500mcg Q3W dosing / placebo QW

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
2004-03-31
Primary Completion
2004-12-31
Completion
2005-01-31

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Diseases
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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 NCT00118638 on ClinicalTrials.gov