Subcutaneous (SC) Darbepoetin Alfa in Subjects With Symptomatic Congestive Heart Failure (CHF) & Anemia - Full Text View

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00086086

Purpose

The purpose of this study is to evaluate whether weight-based or fixed starting doses result in comparable hemoglobin increases and treatment effects in patients with heart failure and anemia.

Condition	Intervention	Phase
Congestive Heart Failure Anemia	Drug: Darbepoetin Alfa	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, Efficacy Study
Official Title:	A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Effects of Treatment With 2 Regimens of Subcutaneous Darbepoetin Alfa (Weight-Based Dosing and Fixed Dosing) on Hemoglobin Concentration Response in Subjects With Symptomatic CHF and Anaemia

Further study details as provided by Amgen:

Primary Outcome Measures:

Rate of rise of hemoglobin concentration

Secondary Outcome Measures:

Change in left ventricular ejection fraction
Change in 6-minute walk distance
NYHA classification
Patient-reported outcomes

Estimated Enrollment:	150
Study Start Date:	June 2004

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria: - Symptomatic CHF for at least 3 months - Reduced left ventricular ejection fraction - Stable heart failure medication - Hemoglobin concentration between 9.0 and 12.5 g/dL Exclusion Criteria: - Hypertension - Unstable angina pectoris or recent myocardial infarction - Likely to receive cardiac transplant - Major organ transplant (e.g., lung, liver, heart) or in renal replacement therapy (e.g., dialysis) - Recent or current treatment for malignancy - Systemic hematologic disease - Anemia due to acute or chronic bleeding - Recent Epogen® or darbepoetin alfa therapy - Recent blood transfusion

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00086086

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

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

Publications of Results:

van Veldhuisen DJ, Dickstein K, Cohen-Solal A, Lok DJ, Wasserman SM, Baker N, Rosser D, Cleland JG, Ponikowski P. Randomized, double-blind, placebo-controlled study to evaluate the effect of two dosing regimens of darbepoetin alfa in patients with heart failure and anaemia. Eur Heart J. 2007 Sep;28(18):2208-16. Epub 2007 Aug 6.

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20020171
Study First Received:	June 23, 2004
Last Updated:	May 15, 2008
ClinicalTrials.gov Identifier:	NCT00086086
Health Authority:	United States: Food and Drug Administration

Keywords provided by Amgen:

Symptomatic Congestive Heart Failure
CHF
Anaemia
Anemia

Study placed in the following topic categories:

Body Weight
Heart Failure
Heart Diseases

Hematologic Diseases
Darbepoetin alfa
Anemia

Additional relevant MeSH terms:

Hematinics
Therapeutic Uses
Hematologic Agents
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009