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

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00117247
First received: June 30, 2005
Last updated: October 15, 2009
Last verified: October 2009

June 30, 2005
October 15, 2009
June 2002
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Pharmacokinetic profiling of Aranesp® in HF pts
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Complete list of historical versions of study NCT00117247 on ClinicalTrials.gov Archive Site
Pharmacodynamic responses (hgb) following Aranesp® administration in HF patients
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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
A Study to Assess the Pharmacokinetics and Pharmacodynamics of Repeat-Sose Subcutaneous Darbepoetin Alfa in Subjects With Congestive Heart Failure and Anemia, and a Single Dose in Healthy Age- and Sex-Matched Control Subjects

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Anemia
  • Congestive Heart Failure
Drug: darbepoetin alfa
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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July 2004
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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

Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
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NCT00117247
20010198
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Global Development Leader, Amgen Inc.
Amgen
Not Provided
Study Director: MD Amgen
Amgen
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP