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| Sponsor: | Alexion Pharmaceuticals |
|---|---|
| Information provided by: | Alexion Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00048308 |
Purpose
During a heart bypass procedure, a substance called "complement" is released by the body. This complement causes inflammation, which can lead to side effects such as chest pain, heart attacks, heart failure, or impairment of memory, language and motor skills. The purpose of this study is to find out if the study drug (pexelizumab), which blocks complement release, can reduce such side effects and be taken safely.
| Condition | Intervention | Phase |
|---|---|---|
|
Cardio-pulmonary Bypass Coronary Artery Bypass Graft |
Drug: pexelizumab |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
The study population will be drawn from patients undergoing CABG or CABG plus valve surgery using a bypass pump. In addition, they must meet all of the following criteria:
EXCLUSION CRITERIA:
A patient will be ineligible for study entry if he/she meets any of the following exclusion criteria:
Contacts and Locations
Show 186 Study Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00048308 History of Changes |
| Other Study ID Numbers: | 2000099, PRIMO-CABG |
| Study First Received: | October 29, 2002 |
| Last Updated: | September 13, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
CABG |
|
Myocardial Infarction Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |