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Sildenafil Citrate for the Treatment of Established Pre-Eclampsia

Last updated on November 16, 2019

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Study Location
Pfizer Investigational Site
Pembury, Kent, TN2 4QJ United Kingdom
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pre-Eclampsia
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Where urgent delivery is indicated

- Where the fetus is suspected to have a structural or chromosomal abnormality

NCT00141310
Pfizer
Terminated
Sildenafil Citrate for the Treatment of Established Pre-Eclampsia

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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 SummaryTo determine the efficacy and safety of sildenafil citrate in the treatment of established pre-eclampsia
Detailed DescriptionNot 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE
 (submitted: August 30, 2005)
76
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2006
Primary Completion DateNot 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 CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyNot Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJuly 2007

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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