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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:

Tracking Information
First Submitted Date  ICMJE August 30, 2005
First Posted Date  ICMJE September 1, 2005
Last Update Posted Date July 25, 2007
Study Start Date  ICMJE September 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2005)
Primary endpoint is the time from randomization to delivery.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00141310 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2005)
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)
Original Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2005)
Individualised birth-weight ratio at delivery and placental weight, Umbilical artery pulsatility index daily until delivery, Other indices of PET, including uric acid and maternal BP daily, until delivery, Safety and toleration, Population PK, fetal
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Sildenafil Citrate for the Treatment of Established Pre-Eclampsia
Official Title  ICMJE 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)
Brief Summary To determine the efficacy and safety of sildenafil citrate in the treatment of established pre-eclampsia
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Pre-Eclampsia
Intervention  ICMJE Drug: Sildenafil citrate
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE
 (submitted: August 30, 2005)
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00141310
Other Study ID Numbers  ICMJE A1481206
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer Call Center Pfizer
PRS Account Pfizer
Verification Date July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP