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NCT00088179 · ClinicalTrials.gov registry record · Phase 3
Pexelizumab in Patients Undergoing Coronary Artery Bypass Grafting With Cardiopulmonary Bypass (PRIMO-CABG II)
A Phase 3 study of Coronary Artery Disease, sponsored by Alexion Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 4,000
- Enrollment target
- 20
- Study locations
NCT00088179: Completed Phase 3 study of Coronary Artery Disease, sponsored by Alexion Pharmaceuticals.
NCT00088179 is a Phase 3 study of Coronary Artery Disease that has completed, run by Alexion Pharmaceuticals. The registered enrollment target is 4,000 participants, above the 1,269-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (215% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00088179, a Phase 3 study of Coronary Artery Disease, has completed, sponsored by Alexion Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 4,000 participants
- Enrollment target
- 20
- Study locations
Study Summary
During a heart bypass procedure, a substance called "complement" is activated by the body. This "complement activation" causes an inflammatory response that can lead to side affects such as chest pain, heart attacks, stroke, heart failure, or death. The purpose of this study is to find out if the study drug (pexelizumab), that blocks "complement activation," can reduce such side effects and be given safely to patients requiring the bypass procedure with the use of the heart-lung machine.
Conditions Studied
Interventions
- DRUG pexelizumab in conjunction with CABG
Study Locations (20)
Alabama
- Brookwood Medical Center - Birmingham
- Baptist Medical Center Princeton - Birmingham
- Baptist Health Systems Montclair - Birmingham
- Medical Center East Hospital - Birmingham
- University of Alabama at Birmingham Hospital - Birmingham
- Thomas Hospital - Fairhope
- Huntsville Hospital - Huntsville
- Mobile Infirmary Medical Center - Mobile
California
- Bakersfield Heart Hospital - Bakersfield
- Seaton Medical Center - Daly City
- Palomar Medical Center - Escondido
- Saddleback Memorial Medical Center - Laguna Hills
- Los Angeles County-University of Southern California Medical Center - Los Angeles
- University of Southern California University Hospital - Los Angeles
Arizona
- Banner Good Samaritan Medical Center - Phoenix
- Arizona Health Sciences Center - Tucson
- University Medical Center - Tucson
- Southern Arizona Veterans Affairs Health Care System - Tucson
Arkansas
- Sparks Regional Medical Center - Fort Smith
- Baptist Medical Center - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,000 participants |
| Start Date | 2004-07 |
| Est. Completion | 2005-10 |
| Phase | Phase 3 |
What the finished NCT00088179 record still lists
NCT00088179 is an interventional study that assigns participants to a tested intervention. Its 4,000 participants enrollment target places it among the larger protocols in the corpus, above the 1,269-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (215% higher).
The record links to 1 condition, with Coronary Artery Disease appearing as the primary indexed condition, and to 1 intervention - of which pexelizumab in conjunction with CABG is the first listed.
NCT00088179 names 20 study sites across 4 states, led by Alabama, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT00088179 about?
NCT00088179 is a clinical study titled "Pexelizumab in Patients Undergoing Coronary Artery Bypass Grafting With Cardiopulmonary Bypass (PRIMO-CABG II)". During a heart bypass procedure, a substance called "complement" is activated by the body. This "complement activation" causes an inflammatory response that can lead to side affects such as chest pain, heart attacks, stroke, heart failure, or death. The purpose of this study is to find out if the st...
What is the current status of trial NCT00088179?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 4,000 participants. The study started on 2004-07. Estimated completion is 2005-10.
What conditions does trial NCT00088179 study?
This clinical trial studies the following conditions: Coronary Artery Disease.
What interventions are being tested in trial NCT00088179?
The interventions under investigation include: pexelizumab in conjunction with CABG (DRUG).
Who is sponsoring clinical trial NCT00088179?
This trial is sponsored by Alexion Pharmaceuticals, which has 162 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00088179 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00088179's enrollment target sits among peer trials
4,000 16th of 219 higher than 201 of 219 other Coronary Artery Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Coronary Artery Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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