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.

First Received: June 30, 2005 Last Updated: December 20, 2007 History of Changes

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00117247

Purpose

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.

Condition	Intervention	Phase
Anemia Congestive Heart Failure	Drug: darbepoetin alfa	Phase I Phase II

MedlinePlus related topics: Anemia Heart Failure

Drug Information available for: Darbepoetin alfa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Pharmacokinetics Study
Official Title:	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

Further study details as provided by Amgen:

Primary Outcome Measures:

Pharmacokinetic profiling of Aranesp® in HF pts

Secondary Outcome Measures:

Pharmacodynamic responses (hgb) following Aranesp® administration in HF patients

Study Start Date:	June 2002
Estimated Study Completion Date:	July 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00117247

Sponsors and Collaborators

Amgen

Investigators

Study Director:

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Publications:

Cleland JG, Sullivan JT, Ball S, Horowitz JD, Agoram B, Rosser D, Yates W, Tin L, Fuentealba P, Burton PB. Once-monthly administration of darbepoetin alfa for the treatment of patients with chronic heart failure and anemia: a pharmacokinetic and pharmacodynamic investigation. J Cardiovasc Pharmacol. 2005 Aug;46(2):155-61.

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20010198
Study First Received:	June 30, 2005
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00117247 History of Changes
Health Authority:	European Union: European Medicines Agency

Keywords provided by Amgen:

Heart Failure

Study placed in the following topic categories:

Heart Failure
Heart Diseases
Hematinics
Hematologic Diseases

Darbepoetin alfa
Anemia
Healthy

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Hematinics
Hematologic Diseases
Therapeutic Uses

Hematologic Agents
Darbepoetin alfa
Anemia
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009