Sildenafil Citrate for the Treatment of Established Pre-Eclampsia

NCT ID: NCT00141310

Last Updated: 2021-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2006-04-30

Brief Summary

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

Detailed Description

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Conditions

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Pre-eclampsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Sildenafil citrate

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Pembury, Kent, United Kingdom

Site Status

Pfizer Investigational Site

Royal Tunbridge Wells, Kent, United Kingdom

Site Status

Pfizer Investigational Site

Ashton-under-Lyne, Lancs, United Kingdom

Site Status

Pfizer Investigational Site

Bolton, , United Kingdom

Site Status

Pfizer Investigational Site

Dundee, , United Kingdom

Site Status

Pfizer Investigational Site

Fife, , United Kingdom

Site Status

Pfizer Investigational Site

London, , United Kingdom

Site Status

Pfizer Investigational Site

London, , United Kingdom

Site Status

Pfizer Investigational Site

Manchester, , United Kingdom

Site Status

Pfizer Investigational Site

Manchester, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 19843000 (View on PubMed)

Related Links

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Other Identifiers

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A1481206

Identifier Type: -

Identifier Source: org_study_id

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