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 II

Further Study Details: 

Primary Outcomes: Primary endpoint is the time from randomization to delivery.
Secondary Outcomes: 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
Expected Total Enrollment:  76

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Female

Criteria

Inclusion Criteria:

• Subjects with pre-eclampsia defined as new hypertension with a diastolic blood pressure of ≥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

Please refer to this study by ClinicalTrials.gov identifier  NCT00141310

Pfizer CT.gov Call Center      1-800-718-1021 

United Kingdom
      Pfizer Investigational Site, Manchester,  M14 0JH,  United Kingdom; Recruiting
      Pfizer Investigational Site, Manchester,  M6 8HD,  United Kingdom; Recruiting
      Pfizer Investigational Site, Manchester,  SK2 7JE,  United Kingdom; No longer recruiting
      Pfizer Investigational Site, Falkirk,  FK1 5QE,  United Kingdom; No longer recruiting
      Pfizer Investigational Site, Dundee,  DD1 9SY,  United Kingdom; Recruiting
      Pfizer Investigational Site, Fife,  KY2 5RA,  United Kingdom; Recruiting
      Pfizer Investigational Site, London,  SW10 9NH,  United Kingdom; Recruiting
      Pfizer Investigational Site, Bolton,  BL4 0JR,  United Kingdom; Recruiting
      Pfizer Investigational Site, London,  SE1 7EH,  United Kingdom; Recruiting
United Kingdom, Kent
      Pfizer Investigational Site, Pembury,  Kent,  TN2 4QJ,  United Kingdom; Recruiting
United Kingdom, Lancs
      Pfizer Investigational Site, Ashton under Lyne,  Lancs,  0L6 9RW,  United Kingdom; Recruiting
United Kingdom, London
      Pfizer Investigational Site, Isleworth,  London,  TW7 6AF,  United Kingdom; Recruiting

Study chairs or principal investigators

Pfizer CT.gov Call Center,  Study Director,  Pfizer   

Study ID Numbers:  A1481206
Last Updated:  August 31, 2005
Record first received:  August 30, 2005
ClinicalTrials.gov Identifier:  NCT00141310
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
ClinicalTrials.gov processed this record on 2005-09-06