Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Amgen |
---|---|
Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00118638 |
The purpose of this study is to evaluate the efficacy of darbepoetin alfa as 500ug once every 3 weeks to show that the dose and schedule are not inferior to darbepoetin alfa administered as 2.25ug/kg once per week in the treatment of anemia in subjects with non-myeloid malignancies.
Condition | Intervention | Phase |
---|---|---|
Anemia Non-Myeloid Malignancies |
Drug: Darbepoetin alfa - 2.25 mcg/kg Drug: Darbepoetin alfa - 500mcg |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double Blind, Active-Controlled Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy |
Enrollment: | 705 |
Study Start Date: | March 2004 |
Study Completion Date: | January 2005 |
Primary Completion Date: | December 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Darbepoetin alfa 500 mcg - Group A: Experimental |
Drug: Darbepoetin alfa - 500mcg
Darbepoetin alfa 500mcg Q3W dosing / placebo QW
|
Darbepoetin alfa 2.25 mcg/kg - Group B: Active Comparator |
Drug: Darbepoetin alfa - 2.25 mcg/kg
Darbepoetin alfa 2.25 mcg/kg QW dosing/ placebo Q3W
|
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: | 20030231 |
Study First Received: | June 30, 2005 |
Last Updated: | March 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00118638 History of Changes |
Health Authority: | Austria: Bundesamt für Sicherheit im Gesundheitswesen; Belgium: Service Public Federal Sante Publiquest, Securite de la Chaine alimentaire et Environnement; Bulgaria: Ministry of Health; Czech Republic: Statni ustav pro kontrolu leciv; Denmark: Laegemiddelstyrelsen; Estonia: State Agency of Medicines; Finland: Lääkelaitos; United Kingdom: Medicines and Healthcare Products Regulatory Agency; France: Afssaps - French Health Products Safety Agency; Germany: Paul_Ehrlich-Institut Bundesamt fur Sera und Impfstoffe; Hungary: National Institute of Pharmacy; Italy: Local Ethics Committees; Latvia: State Agency of Medicines; Lithuania: State Medicines Control Agency of Lithuania; Netherlands: Medisch Centrum Rijnmond_Zuid, lcatie Zuider; Norway: Norwegian Medicines Agency; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Portugal: Instituto Nacional da Farmácia e do Medicamento (INFARMED); Romania: Ministry of Health and the Family; Slovakia: Štátny ústav pre kontrolu lieciv; Spain: Agencia Española de Medicamentos y Productos Sanitarios; Sweden: Medical Products Agency; Switzerland: Agency for Therapeutic Products; Ukraine: Ministry of Health |
Non-myeloid malignancy Darbepoetin alfa Clinical Trial |
Hematinics Hematologic Diseases Darbepoetin alfa Anemia |
Neoplasms Hematinics Hematologic Diseases Therapeutic Uses |
Hematologic Agents Darbepoetin alfa Anemia Pharmacologic Actions |