Darbepoetin Alfa Administered Once Every 4 Weeks in the Treatment of Subjects With Anemia of Cancer
This study has been completed.
Information provided by:
First received: November 2, 2004
Last updated: March 12, 2009
Last verified: March 2009
The purpose of this trial is to demonstrate benefit with respect to hematopoietic response in subjects with anemia of cancer randomized to Darbepoetin Alfa once every 4 weeks.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Darbepoetin Alfa Administered Once Every 4 Weeks in the Treatment of Subjects With Anemia of Cancer|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Amgen:
Primary Outcome Measures:
- To demonstrate benefit with respect to hematopoietic response in subjects with anemia of cancer randomized to darbepoetin alfa once every 4 weeks.
Secondary Outcome Measures:
- Assess efficacy
- Assess PROs
- Assess relationship between PROs and hemoglobin concentration
- Assess safety of dose and frequency
|Study Start Date:||October 2004|
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