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NCT00141310 Clinical Trial

Sildenafil Citrate for the Treatment of Established Pre-Eclampsia

Pre-eclampsia Clinical Trial

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 Mg TID for the Treatment of Pre-Eclampsia. (PET)

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00141310
Other study ID # A1481206
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date September 2004
Est. completion date April 2006

Study information
Verified date January 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Terminated
Enrollment 76
Est. completion date April 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Sildenafil citrate

Locations
Country Name City State
United Kingdom Pfizer Investigational Site Ashton under Lyne Lancs
United Kingdom Pfizer Investigational Site Bolton
United Kingdom Pfizer Investigational Site Dundee
United Kingdom Pfizer Investigational Site Fife
United Kingdom Pfizer Investigational Site London
United Kingdom Pfizer Investigational Site London
United Kingdom Pfizer Investigational Site Manchester
United Kingdom Pfizer Investigational Site Manchester
United Kingdom Pfizer Investigational Site Pembury Kent
United Kingdom Pfizer Investigational Site Royal Tunbridge Wells Kent

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Primary endpoint is the time from randomization to delivery.
Secondary 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)
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