FDA Resources. Arms and Interventions. Participants received dose and administration schedule every 2 weeks or once a month changes that simulated the changes for participants receiving darbepoetin alfa. Outcome Measures.
Primary Outcome Measures : Time to All Cause Death or First Hospitalization for Worsening Heart Failure [ Time Frame: From randomization to the end of study; maximum time on study was 73 months ] Time to death from any cause or first hospital admission for worsening heart failure adjudicated by the Clinical Endpoint Committee , whichever occurred first, estimated by Kaplan-Meier method.
Time to cardiovascular death or first hospital admission for worsening heart failure, whichever occured first, estimated using the Kaplan Meier method. The KCCQ is a disease-specific patient-reported outcomes measure for patients with heart failure. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision.
Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials. More Information. Additional Information: AmgenTrials clinical trials website. Eur J Heart Fail. Erratum in: Eur J Heart Fail. Treatment of anemia with darbepoetin alfa in systolic heart failure. N Engl J Med. Epub Mar Clin Res Cardiol. Epub Jul Circ Heart Fail.
Survival study morbidity and mortality heart failure hospitalization all-cause death patient-reported outcomes Kansas City Cardiomyopathy questionnaire anemia treatment.
National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Drug: Darbepoetin alfa Drug: Placebo. Phase 3. Study Type :. Interventional Clinical Trial.
Actual Enrollment :. Actual Study Start Date :. Actual Primary Completion Date :. Actual Study Completion Date :. Experimental: Darbepoetin alfa Starting dose of 0. Placebo Comparator: Placebo Participants received dose and administration schedule every 2 weeks or once a month changes that simulated the changes for participants receiving darbepoetin alfa. Drug: Placebo Placebo subcutaneous injection. Los Angeles, California, United States, Westlake Village, California, United States, Colorado Springs, Colorado, United States, Red Hat product trial center.
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