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Sildenafil Citrate for the Treatment of Established Pre-Eclampsia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00141310
Recruitment Status : 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.)
First Posted : September 1, 2005
Last Update Posted : July 25, 2007
Information provided by:

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

Condition or disease Intervention/treatment Phase
Pre-Eclampsia Drug: Sildenafil citrate Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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)
Study Start Date : September 2004
Actual Study Completion Date : April 2006

Primary Outcome Measures :
  1. Primary endpoint is the time from randomization to delivery.

Secondary Outcome Measures :
  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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00141310

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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, SE1 7EH
Pfizer Investigational Site
London, United Kingdom, SW10 9NH
Pfizer Investigational Site
Manchester, United Kingdom, M14 0JH
Pfizer Investigational Site
Manchester, United Kingdom, M6 8HD
Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00141310    
Other Study ID Numbers: A1481206
First Posted: September 1, 2005    Key Record Dates
Last Update Posted: July 25, 2007
Last Verified: July 2007
Additional relevant MeSH terms:
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Hypertension, Pregnancy-Induced
Pregnancy Complications
Sildenafil Citrate
Citric Acid
Sodium Citrate
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Urological Agents