Sildenafil Citrate for the Treatment of Established Pre-Eclampsia

• ClinicalTrials.gov Identifier: NCT00141310
• Recruitment Status: Terminated
• First Posted: September 1, 2005
• Last Update Posted: July 25, 2007
• Sponsor: Pfizer
• Information provided by: Pfizer

Tracking Information

• First Submitted Date: August 30, 2005
• First Posted Date: September 1, 2005
• Last Update Posted Date: July 25, 2007
• Study Start Date: September 2004
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: August 30, 2005): Primary endpoint is the time from randomization to delivery.
• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT00141310 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures (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 (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: Sildenafil Citrate for the Treatment of Established Pre-Eclampsia
• 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)
• Brief Summary: To determine the efficacy and safety of sildenafil citrate in the treatment of established pre-eclampsia
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
• Condition: Pre-Eclampsia
• Intervention: Drug: Sildenafil citrate
• Study Arms: 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.

Recruitment Information

• Recruitment Status: Terminated
• Enrollment (submitted: August 30, 2005): 76
• Original Enrollment: Same as current
• Actual Study Completion Date: April 2006
• Primary Completion Date: Not Provided

Eligibility Criteria

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

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT00141310
• Other Study ID Numbers: A1481206
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: July 2007