NCT00117234

Brief Summary

The purpose of this study was to evaluate the effect of treatment with darbepoetin alfa on peak oxygen consumption (peak VO2) in subjects with symptomatic CHF and anemia.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Sep 2002

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 6, 2005

Completed
Last Updated

December 3, 2010

Status Verified

December 1, 2010

First QC Date

June 30, 2005

Last Update Submit

December 2, 2010

Conditions

Congestive Heart FailureAnemia

Keywords

chronic heart failurecongestive heart failurelow hemoglobinanemiaCHFSymptomatic Congestive Heart Failure (CHF)

Outcome Measures

Primary Outcomes (1)

  • Exercise tolerance, measured as peak VO(subscript)2

Secondary Outcomes (1)

  • Exercise duration; *NYHA classification; *Patient-reported outcomes

Interventions

darbepoetin alfaDRUG

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Ponikowski P, Anker SD, Szachniewicz J, Okonko D, Ledwidge M, Zymlinski R, Ryan E, Wasserman SM, Baker N, Rosser D, Rosen SD, Poole-Wilson PA, Banasiak W, Coats AJ, McDonald K. Effect of darbepoetin alfa on exercise tolerance in anemic patients with symptomatic chronic heart failure: a randomized, double-blind, placebo-controlled trial. J Am Coll Cardiol. 2007 Feb 20;49(7):753-62. doi: 10.1016/j.jacc.2006.11.024. Epub 2007 Feb 5.

    PMID: 17306703DERIVED

Related Links

MeSH Terms

Conditions

Heart FailureAnemia

Interventions

Darbepoetin alfa

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 30, 2005

First Posted

July 6, 2005

Study Start

September 1, 2002

Study Completion

July 1, 2004

Last Updated

December 3, 2010

Record last verified: 2010-12