Sildenafil Citrate for the Treatment of Established Pre-Eclampsia

• Status: Terminated
• Trial end date: 2006-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

To determine the efficacy and safety of sildenafil citrate in the treatment of established pre-eclampsia

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer; Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Treatments: Citric Acid; Sildenafil Citrate

Criteria

Inclusion Criteria:

• Subjects with pre-eclampsia defined as new hypertension with a diastolic BP of > or = 90 mmHg on two occasions separated by at least 4 hrs arising after 20 weeks of pregnancy, associated with >500 mg/24 hr proteinuria. Subjects with pre-existing hypertension (on treatment) need only fulfill proteinuria requirement.

• Gestational age 24-34 w

• Singleton pregnancy

Exclusion Criteria:

• Where urgent delivery is indicated

• Where the fetus is suspected to have a structural or chromosomal abnormality