drugset

drugset / Trial / NCT01670136

Pharmacokinetics of Sildenafil in Premature Infants

NCT01670136 ↗

Phase 1 Completed 34 enrolled University of North Carolina, Chapel Hill Duke University · collab Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collab The Emmes Company, LLC · collab

Non-randomizedSingle-groupOpen-labelBasic science

Summary

The purpose of this study is to learn more about the safety and dosing of sildenafil in infants.

Timeline

Start: 2013-02
Primary completion: 2016-07
Completion: 2016-07

Publications

Jackson W, Gonzalez D, Smith PB, Ambalavanan N, Atz AM, Sokol GM, Hornik CD, Stewart D, Mundakel G, Poindexter BB, Ahlfeld SK, Mills M, Cohen-Wolkowiez M, Martz K, Hornik CP, Laughon MM; Best Pharmaceuticals for Children Act-Pediatric Trials Network Steering Committee. Safety of sildenafil in extremely premature infants: a phase I trial. J Perinatol. 2022 Jan;42(1):31-36. doi: 10.1038/s41372-021-01261-w. Epub 2021 Nov 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sildenafil	Unknown	0.125 mg/kg	Intravenous
Subject	Sildenafil	Unknown	0.25 mg/kg	Intravenous

Indications