Clinical Trial: Sildenafil Citrate for the Treatment of Established Pre-Eclampsia

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Randomised, Double-Blind, Placebo-Controlled, Flexible-Dose, Parallel-Group Study to Evaluate the Efficacy, Safety and Toleration of Oral Sildenafil Citrate Administered in the Dose Range of 20 - 80

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

Detailed Summary:
Sponsor: Pfizer

Current Primary Outcome: Primary endpoint is the time from randomization to delivery.

Original Primary Outcome: Same as current

Current Secondary Outcome: Individualised birth-weight ratio at delivery, Placental weight, Umbilical artery pulsatility index, Other indices of PET (incl. uric acid and maternal BP), Safety and toleration, Population PK, Fetal exposure (PK)

Original Secondary Outcome: Individualised birth-weight ratio at delivery and placental weight, Umbilical artery pulsatility index daily until delivery, Other indices of PET, including uric acid and maternal BP daily, until delivery, Safety and toleration, Population PK, fetal

Information By: Pfizer

Dates:
Date Received: August 30, 2005
Date Started: September 2004
Date Completion:
Last Updated: July 23, 2007
Last Verified: July 2007