Sildenafil Citrate for the Treatment of Established Pre-Eclampsia

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00141310
• Collaborator: (none)
• Enrollment: 76
• Locations: 10
• Duration (Months): 19
• Patients Per Site: 7.6
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pre-eclampsia	Drug: Sildenafil citrate	Phase 2

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• 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)
• Study Start Date: Sep 1, 2004
• Actual Study Completion Date: Apr 1, 2006

Outcome Measures

Primary Outcome Measures

1. Primary endpoint is the time from randomization to delivery. []

Secondary Outcome Measures

1. 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) []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	Pfizer Investigational Site	Dundee		United Kingdom	DD1 9SY
6	Pfizer Investigational Site	Fife		United Kingdom	KY2 5RA
7	Pfizer Investigational Site	London		United Kingdom	SE1 7EH
8	Pfizer Investigational Site	London		United Kingdom	SW10 9NH
9	Pfizer Investigational Site	Manchester		United Kingdom	M14 0JH
10	Pfizer Investigational Site	Manchester		United Kingdom	M6 8HD

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• ClinicalTrials.gov Identifier: NCT00141310
• Other Study ID Numbers: A1481206
• First Posted: Sep 1, 2005
• Last Update Posted: Feb 1, 2021
• Last Verified: Jan 1, 2021

• Additional relevant MeSH terms: Eclampsia; Pre-Eclampsia; Sildenafil Citrate

Study Results

No Results Posted as of Feb 1, 2021