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

August 30, 2005
July 23, 2007
September 2004
Not Provided
Primary endpoint is the time from randomization to delivery.
Same as current
Complete list of historical versions of study NCT00141310 on ClinicalTrials.gov Archive Site
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)
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
Not Provided
Not Provided
 
Sildenafil Citrate for the Treatment of Established Pre-Eclampsia
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)

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Pre-Eclampsia
Drug: Sildenafil citrate
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
76
April 2006
Not Provided

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00141310
A1481206
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2007

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