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Study Complete
Sponsor ID
20020171

Subcutaneous (SC) Darbepoetin Alfa in Subjects with Symptomatic Congestive Heart Failure (CHF) & Anemia

Sponsor ID
20020171
Clinicaltrials.gov ID
NCT00086086
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

The purpose of this study is to evaluate whether weight-based or

fixed starting doses result in comparable hemoglobin increases and treatment

effects in patients with heart failure and anemia.

Additional Study Details

Phase
Phase 2
Product
darbepoetin alfa
Type
Interventional
Masking
N/A
Enrollment
150
Additional Study Details

Protocol Summary

Primary Outcome Measures
Not Available
Secondary Outcome Measures
Not Available

Locations

No locations found.
Study Info
Age
21+ years
Condition
  • Heart Failure
  • Anemia
    • Sex
    All
    Trial Dates
    Aug 2003 - N/A
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Symptomatic CHF for at least 3 months - Reduced left ventricular ejection fraction - Stable heart failure medication - Hemoglobin concentration between 9.0 and 12.5 g/dL
    Exclusion Criteria:
    - Hypertension - Unstable angina pectoris or recent myocardial infarction - Likely to receive cardiac transplant - Major organ transplant (e.g., lung, liver, heart) or in renal replacement therapy (e.g., dialysis) - Recent or current treatment for malignancy - Systemic hematologic disease - Anemia due to acute or chronic bleeding - Recent Epogen® or darbepoetin alfa therapy - Recent blood transfusion