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Sildenafil Citrate for the Treatment of Established Pre-Eclampsia

This study has been terminated.
(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.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00141310
First received: August 30, 2005
Last updated: July 23, 2007
Last verified: July 2007
History of Changes
  Purpose

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


Condition Intervention Phase
Pre-Eclampsia
 Drug: Sildenafil citrate
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

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)

Estimated Enrollment: 76
Study Start Date: September 2004
Study Completion Date: April 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00141310

Locations
United Kingdom
Pfizer Investigational Site
Pembury, Kent, United Kingdom, TN2 4QJ
Pfizer Investigational Site
Royal Tunbridge Wells, Kent, United Kingdom, TN1 1JU
Pfizer Investigational Site
Ashton under Lyne, Lancs, United Kingdom, 0L6 9RW
Pfizer Investigational Site
Bolton, United Kingdom, BL4 0JR
Pfizer Investigational Site
Dundee, United Kingdom, DD1 9SY
Pfizer Investigational Site
Fife, United Kingdom, KY2 5RA
Pfizer Investigational Site
London, United Kingdom, SW10 9NH
Pfizer Investigational Site
London, United Kingdom, SE1 7EH
Pfizer Investigational Site
Manchester, United Kingdom, M14 0JH
Pfizer Investigational Site
Manchester, United Kingdom, M6 8HD
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00141310     History of Changes
Other Study ID Numbers: A1481206
Study First Received: August 30, 2005
Last Updated: July 23, 2007
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Eclampsia
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Citric Acid
Sildenafil
Anticoagulants
Hematologic Agents
Therapeutic Uses
 Pharmacologic Actions
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Cardiovascular Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on June 18, 2013