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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00091858 |
The purpose of this study is to evaluate the efficacy of darbepoetin alfa versus placebo in reducing the occurrences of red blood cell transfusions in subjects with anemia of cancer who are not receiving chemotherapy.
Condition | Intervention | Phase |
---|---|---|
Anemia Cancer |
Drug: Darbepoetin Alfa Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Darbepoetin Alfa for the Treatment of Anemia of Cancer |
Estimated Enrollment: | 1000 |
Study Start Date: | April 2004 |
Study Completion Date: | December 2006 |
Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Darbepoetin alfa 6.75 mcg/kg Q4W: Experimental |
Drug: Darbepoetin Alfa
6.75 mcg/kg Q4W
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Placebo Q4W: Placebo Comparator |
Drug: Placebo
Placebo Q4W
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20010103 |
Study First Received: | September 17, 2004 |
Last Updated: | May 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00091858 |
Health Authority: | Australia: Therapeutic Goods Administration; Austria: Bundesamt für Sicherheit im Gesundheitswesen; Belgium: Service Public Fédéral Santé Publique, Sécurité de la Chaîne alimentaire et Environnement; Canada: Health Canada; Czech Republic: Statni ustav pro kontrolu leciv; Estonia: State Agency of Medicines; Hungary: National Institute of Pharmacy; Italy: Ministry of Health; Latvia: State Agency of Medicines; Romania: Ministry of Health and the Family; Russia: Ministry of Health; Slovakia: Štátny ústav pre kontrolu lieciv; Spain: Agencia Española de Medicamentos y Productos Sanitarios; Switzerland: Agency for Therapeutic Products; Ukraine: Ministry of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration; Lithuania: State Medicines Control Agency of Lithuania; Netherlands: Medicines Evaluation Board; Netherlands: Medisch Centrum Rijnmond_Zuid, lcatie Zuider; Poland: Drug Institut; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Portugal: Instituto Nacional da Farmácia e do Medicamento (INFARMED) |
Cancer-related anemia |
Hematologic Diseases Darbepoetin alfa Anemia |
Hematinics Therapeutic Uses Hematologic Agents Pharmacologic Actions |