Sildenafil Citrate for the Treatment of Established Pre-Eclampsia

Viatris

Status and phase: Terminated; Phase 2

Conditions: Pre-eclampsia

Treatments: Drug: Sildenafil citrate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00141310

A1481206

Details and patient eligibility

About

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

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind