Clinical Trial of a COX-2 Inhibitor for the Treatment of Women With Preeclampsia
Withdrawn before enrolling · Phase 2 · Has a placebo group
Conditions studied: Preeclampsia
In brief
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 with increased expression of COX-2. This study will test the hypothesis that treatment of women with a COX-2 inhibitor, celecoxib, will stop the inflammatory process and reverse symptoms of preeclampsia.
Key facts
- Study ID
- NCT00442676
- Run by
- Virginia Commonwealth University
- People needed
- 0
- Starts
- 2009-06-01
- Expected to finish
- 2010-01-01
- Last updated by the study team
- 2012-03-13
Who can join
Age: 18 and older, up to 40. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- MCV Main Hospital — Richmond, Virginia, United States
Full record on ClinicalTrials.gov
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