Tracking Information
Start Date ICMJE | June 2006 |
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Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: January 31, 2008) | To determine the efficacy of darbepoetin alfa compared to placebo on the composite of time to death from any cause or first hospital admission for worsening HF in subjects with symptomatic left ventricular systolic dysfunction and anemia. [ Time Frame: Duration of study ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE (submitted: July 27, 2006) | To determine the efficacy of darbepoetin alfa compared with placebo on the composite of time to death from any cause or first hospital admission for worsening HF in subjects with symptomatic left ventricular systolic dysfunction and anemia. |
Change History | Complete list of historical versions of study NCT00358215 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: January 31, 2008) |
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Original Secondary Outcome Measures ICMJE (submitted: July 27, 2006) |
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Descriptive Information
Brief Title ICMJE | RED-HF™ Trial - Reduction of Events With Darbepoetin Alfa in Heart Failure Trial |
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Official Title ICMJE | 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 |
Brief 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 HF in subjects with symptomatic left ventricular systolic dysfunction and anemia. |
Detailed Description | Several epidemiological studies have demonstrated an association between HF and anemia and correlation of increased risk for mortality and hospitalization with low hemoglobin in patients with HF. Earlier single-center interventional studies suggest that meaningful clinical benefits may be achieved by raising hemoglobin concentration in patients with symptomatic HF and anemia. Data from Amgen's completed phase 2 multi-center studies support this hypothesis and show that darbepoetin alfa is well tolerated in patients with symptomatic left ventricular systolic dysfunction and anemia and effectively raises hemoglobin. The pivotal phase 3 Study 20050222 RED-HF Trial is evaluating the effect of treatment with darbepoetin alfa on the composite risk of all-cause mortality or hospitalization for worsening HF in subjects with symptomatic left ventricular systolic dysfunction and anemia. This study also evaluates the effect of darbepoetin alfa treatment on all-cause death, on cardiovascular death or hospitalization for worsening HF, and on patient-reported quality-of-life outcomes. |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE |
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Intervention ICMJE |
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Study Arms / Comparison Groups |
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Publications * | McMurray JJ, Anand IS, Diaz R, Maggioni AP, O'Connor C, Pfeffer MA, Polu KR, Solomon SD, Sun Y, Swedberg K, Tendera M, van Veldhuisen DJ, Wasserman SM, Young JB; RED-HF Committees and Investigators. Design of the Reduction of Events with Darbepoetin alfa in Heart Failure (RED-HF): a Phase III, anaemia correction, morbidity-mortality trial. Eur J Heart Fail. 2009 Aug;11(8):795-801. |
Recruitment Information
Estimated Enrollment ICMJE | 2600 | ||||
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Estimated Completion Date | April 2012 | ||||
Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hungary, India, Israel, Italy, Latvia, Lithuania, Mexico, Netherlands, Norway, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Slovakia, Spain, Sweden, Switzerland, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT00358215 | ||||
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Responsible Party | Global Development Leader, Amgen Inc. | ||||
Study ID Numbers ICMJE | 20050222, RED-HF™ Trial | ||||
Study Sponsor ICMJE | Amgen | ||||
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Investigators ICMJE |
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Information Provided By | Amgen |