Status:
COMPLETED
A Study of Repeat-Dose Subcutaneous Darbepoetin Alfa in Subjects With Congestive Heart Failure and Anemia, and a Single Dose in Healthy Age- and Sex-Matched Control Subjects
Lead Sponsor:
Amgen
Conditions:
Anemia
Congestive Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to evaluate the single dose pharmacokinetics (PK) of subcutaneous (SC) darbepoetin alfa in subjects with congestive heart failure (CHF) and anemia.
Eligibility Criteria
Inclusion
- Inclusion Criteria: - Symptomatic CHF despite optimized therapy for at least the previous 3 months (treatment included a diuretic, angiotensin converting enzyme \[ACE\] inhibitor, and/or an A2 antagonist, unless not tolerated) - Hemoglobin greater than or equal to 12.5 g/dL at the time of screening
Exclusion
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
End Date :
July 1 2004
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00117247
Start Date
June 1 2002
End Date
July 1 2004
Last Update
October 16 2009
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