Sildenafil Citrate for the Treatment of Established Pre-Eclampsia

Phase 2

Terminated

• Conditions: Pre-eclampsia

• Registration Number: NCT00141310
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2005-08-30
• Study First Submitted QC: 2005-08-30
• Study First Posted: 2005-09-01
• Study Completion: 2006-04
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-28
• Last Update Posted: 2021-02-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 76

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Primary endpoint is the time from randomization to delivery.

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 Manchester, United Kingdom