Status:
WITHDRAWN
Clinical Trial of a COX-2 Inhibitor for the Treatment of Women With Preeclampsia
Lead Sponsor:
Virginia Commonwealth University
Conditions:
Preeclampsia
Eligibility:
FEMALE
18-40 years
Phase:
PHASE2
Brief Summary
Preeclampsia is a hypertensive disorder of pregnancy and a leading cause of fetal and maternal morbidity and mortality. Recent findings indicate preeclampsia is an inflammatory disorder associated wit...
Eligibility Criteria
Inclusion
- Pregnant women with preeclampsia between 20 - 32 weeks gestation. Preeclampsia is defined as a maternal blood pressure of \>140/90 mmHg on two readings at least 6 hours apart with proteinuria of \>300 mg/24 hours.
Exclusion
- Exclusion criteria includes patients with known sensitivity to celecoxib; patients who have demonstrated allergic-type reactions to sulfonamides; patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Other exclusion criteria will include patients with known cardiovascular disease or risk factors for cardiovascular disease, a prior history of ulcer disease or GI bleeding, impaired renal function, or liver dysfunction. Exclusion criteria will also include concomitant use of oral corticosteroids, anticoagulants, diuretics, ACE inhibitors, aspirin, fluconazole, and lithium.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00442676
Start Date
June 1 2009
End Date
January 1 2010
Last Update
March 13 2012
Active Locations (1)
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1
MCV Main Hospital
Richmond, Virginia, United States, 23298