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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)

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00141310
Enrollment
76
Registered
2005-09-01
Start date
2004-09-30
Completion date
2006-04-30
Last updated
2021-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre-eclampsia

Brief summary

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

Interventions

DRUGSildenafil citrate

Sponsors

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Primary endpoint is the time from randomization to delivery.—

Secondary

MeasureTime frame
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)—

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026