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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00049985 |
The purpose of this study is to determine whether increasing hemoglobin concentration in patients with heart failure and anemia will improve the patients' functional status, including exercise tolerance and New York Heart Association (NYHA) classification.
Condition | Intervention | Phase |
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Heart Failure Anemia |
Drug: Darbepoetin Alfa |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Impact of Subcutaneous (SC) Darbepoetin Alfa Treatment on Exercise Tolerance in Subjects With Symptomatic Heart Failure (CHF) and Anemia. |
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria: - At least 21 years of age - Symptomatic CHF for at least 3 months - Limited exercise tolerance on a treadmill - Reduced left ventricular ejection fraction - Stable heart failure medication - Hemoglobin concentration between 9.0 and 12.5 g/dL Exclusion Criteria: - Hypertension
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20010170 |
Study First Received: | November 18, 2002 |
Last Updated: | December 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00049985 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Heart Failure Heart Diseases Hematinics |
Hematologic Diseases Darbepoetin alfa Anemia |
Heart Failure Heart Diseases Hematinics Hematologic Diseases Therapeutic Uses |
Hematologic Agents Darbepoetin alfa Anemia Cardiovascular Diseases Pharmacologic Actions |