Status:
TERMINATED
Sildenafil Citrate for the Treatment of Established Pre-Eclampsia
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Pre-eclampsia
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
To determine the efficacy and safety of sildenafil citrate in the treatment of established pre-eclampsia
Eligibility Criteria
Inclusion
- 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
- Where urgent delivery is indicated
- Where the fetus is suspected to have a structural or chromosomal abnormality
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
End Date :
April 1 2006
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00141310
Start Date
September 1 2004
End Date
April 1 2006
Last Update
February 1 2021
Active Locations (10)
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1
Pfizer Investigational Site
Pembury, Kent, United Kingdom, TN2 4QJ
2
Pfizer Investigational Site
Royal Tunbridge Wells, Kent, United Kingdom, TN1 1JU
3
Pfizer Investigational Site
Ashton-under-Lyne, Lancs, United Kingdom, 0L6 9RW
4
Pfizer Investigational Site
Bolton, United Kingdom, BL4 0JR