Pharmacokinetic/ Pharmacodynamic Study of Epoetin Alfa (PROCRIT) in Critically Ill Patients.
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|ClinicalTrials.gov Identifier: NCT00210756|
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : June 10, 2011
|Condition or disease||Intervention/treatment||Phase|
|Anemia Critical Illness||Drug: epoetin alfa||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparative Pharmacokinetic and Pharmacodynamic Study of Epoetin Alfa (PROCRIT) in Anemic Critically Ill Patients Randomized to One of Six Dose Regimens for 15 Days|
|Study Start Date :||February 2004|
|Actual Study Completion Date :||February 2006|
- The primary objective of this study is to describe the PK profiles of six different dosing regimens of epoetin alfa in anemic critically ill subjects, including regimen A, that is being used in a large registration trial
- To determine reticulocyte response (absolute and %) to the six dosing regimens, as well as the Hb, Hct, and RBC count response. Compare the PD profiles of each dosing regimen to dosing regimen A. describe the safety profile of the six dosing regimens.
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.gov identifier (NCT number): NCT00210756
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|