Study Stopped
Study prematurely discont'd 20-Apr-2006 after interim analysis suggested sample size could be reduced without losing power. No safety concerns led to decision.
Sildenafil Citrate for the Treatment of Established Pre-Eclampsia
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)
1 other identifier
interventional
76
1 country
10
Brief Summary
To determine the efficacy and safety of sildenafil citrate in the treatment of established pre-eclampsia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2004
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 30, 2005
CompletedFirst Posted
Study publicly available on registry
September 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2006
CompletedFebruary 1, 2021
January 1, 2021
August 30, 2005
January 28, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Primary endpoint is the time from randomization to delivery.
Secondary Outcomes (1)
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)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Where urgent delivery is indicated
- Where the fetus is suspected to have a structural or chromosomal abnormality
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Pfizer Investigational Site
Pembury, Kent, TN2 4QJ, United Kingdom
Pfizer Investigational Site
Royal Tunbridge Wells, Kent, TN1 1JU, United Kingdom
Pfizer Investigational Site
Ashton-under-Lyne, Lancs, 0L6 9RW, United Kingdom
Pfizer Investigational Site
Bolton, BL4 0JR, United Kingdom
Pfizer Investigational Site
Dundee, DD1 9SY, United Kingdom
Pfizer Investigational Site
Fife, KY2 5RA, United Kingdom
Pfizer Investigational Site
London, SE1 7EH, United Kingdom
Pfizer Investigational Site
London, SW10 9NH, United Kingdom
Pfizer Investigational Site
Manchester, M14 0JH, United Kingdom
Pfizer Investigational Site
Manchester, M6 8HD, United Kingdom
Related Publications (1)
Samangaya RA, Mires G, Shennan A, Skillern L, Howe D, McLeod A, Baker PN. A randomised, double-blinded, placebo-controlled study of the phosphodiesterase type 5 inhibitor sildenafil for the treatment of preeclampsia. Hypertens Pregnancy. 2009 Aug;28(4):369-82. doi: 10.3109/10641950802601278.
PMID: 19843000DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2005
First Posted
September 1, 2005
Study Start
September 1, 2004
Study Completion
April 1, 2006
Last Updated
February 1, 2021
Record last verified: 2021-01