Sildenafil Citrate for the Treatment of Established Pre-Eclampsia

NCT00141310 ↗

Phase 2 Terminated 76 enrolled Viatris Inc.

RandomizedParallel-groupDouble-blindTreatment

Summary

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

Timeline

Start: 2004-09
Primary completion: —
Completion: 2006-04

Outcome

Missed primary endpoint

Stopped: “Study prematurely discont'd 20-Apr-2006 after interim analysis suggested sample size could be reduced without losing power. No safety concerns led to decision.”

paper did not prolong pregnancy duration in women with preeclampsia. PMID 19843000 ↗

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sildenafil	Unknown	80 mg	Oral