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Sildenafil Citrate for the Treatment of Established Pre-Eclampsia

Primary Purpose

Pre-eclampsia

Status
Terminated
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Sildenafil citrate
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pre-eclampsia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

Primary Outcome Measures

Primary endpoint is the time from randomization to delivery.

Secondary Outcome Measures

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)

Full Information

First Posted
August 30, 2005
Last Updated
January 28, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00141310
Brief Title
Sildenafil Citrate for the Treatment of Established Pre-Eclampsia
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Terminated
Why 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.
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-eclampsia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
76 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Sildenafil citrate
Primary Outcome Measure Information:
Title
Primary endpoint is the time from randomization to delivery.
Secondary Outcome Measure Information:
Title
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)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Pembury
State/Province
Kent
ZIP/Postal Code
TN2 4QJ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Royal Tunbridge Wells
State/Province
Kent
ZIP/Postal Code
TN1 1JU
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Ashton under Lyne
State/Province
Lancs
ZIP/Postal Code
0L6 9RW
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Bolton
ZIP/Postal Code
BL4 0JR
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Fife
ZIP/Postal Code
KY2 5RA
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
London
ZIP/Postal Code
SW10 9NH
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Manchester
ZIP/Postal Code
M14 0JH
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Manchester
ZIP/Postal Code
M6 8HD
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
19843000
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1481206&StudyName=Sildenafil%20Citrate%20for%20the%20Treatment%20of%20Established%20Pre-Eclampsia
Description
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Sildenafil Citrate for the Treatment of Established Pre-Eclampsia

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