At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 2,278 enrolled
Drug / intervention
Darbepoetin alfa +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Darbepoetin Alfa Treatment on Mortality and Morbidity in Heart Failure (HF) Subjects With Symptomatic Left Ventricular Systolic Dysfunction and Anemia
In Brief
A Phase 3 clinical trial evaluating Darbepoetin alfa and Placebo for Heart Failure and 4 related conditions. Completed, enrolled 2,278 participants across 754 sites in 36 countries.
Detailed Summary
The purpose of the study is to determine the efficacy of treatment of anemia with darbepoetin alfa compared to placebo on the composite of time to death from any cause or first hospital admission for worsening heart failure in patients with symptomatic left ventricular systolic dysfunction and anemia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure, Anemia, Cardiovascular Disease, Ventricular Dysfunction, Congestive Heart Failure
CountriesArgentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Czechia, Denmark, Estonia, Finland, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Latvia, Lithuania, Mexico, Netherlands, Norway, Poland, Portugal, Puerto Rico, Romania, Russia, Slovakia, South Africa, Spain, Sweden, Switzerland, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2006
First PostedJul 2006
Primary CompletionOct 2012
TodayJul 2026
First PostedJul 31, 2006
Enrollment StartJun 1, 2006
Primary CompletionOct 11, 2012
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 19.9 years ago
Interventions
Darbepoetin alfadrug
Administered by subcutaneous injection
Placebodrug
Placebo subcutaneous injection