Status:
COMPLETED
A Study Comparing the Efficacy and Safety of Valdecoxib Plus Parecoxib Versus Valdecoxib Plus Placebo for the Treatment of Pain After Coronary Artery Bypass Surgery
Lead Sponsor:
Pfizer
Conditions:
Pain
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of parecoxib/valdecoxib therapy and placebo/valdecoxib therapy for the treatment of pain after coronary artery bypass surgery
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients expected to receive in-hospital pain medication for pain after coronary artery bypass graft surgery for at least 3 full days and pain medication over a 10-day period
- New York Heart Association Class I to III or cardiac ejection fraction of at least 35% before surgery
- Body mass index of less than or equal to 40 kg/m2 and weight of \>55 kg
- Patients scheduled to undergo an isolated (bypass grafting only without valve replacement, significant aortic reconstruction, or ventriculoplasty) primary CABG surgery via median sternotomy, using cardiopulmonary bypass
- Exclusion criteria:
- Patient has undergone or is going to have emergency coronary artery bypass graft surgery or surgery without cardiopulmonary bypass procedure
- Symptomatic peripheral vascular disease
- Heart attack within 48 hours of surgery
Exclusion
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2004
Estimated Enrollment :
1671 Patients enrolled
Trial Details
Trial ID
NCT00636064
Start Date
January 1 2003
End Date
January 1 2004
Last Update
October 10 2008
Active Locations (206)
Enter a location and click search to find clinical trials sorted by distance.
1
Pfizer Investigational Site
Fairhope, Alabama, United States, 36532
2
Pfizer Investigational Site
Mobile, Alabama, United States, 36602
3
Pfizer Investigational Site
Mobile, Alabama, United States, 36604
4
Pfizer Investigational Site
Mobile, Alabama, United States, 36607