A Study to Determine the Pharmacokinetic Profile, Safety and Tolerability of Sildenafil (REVATIO®) in Cardiac Surgery

PHASE1CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

June 30, 2013

Primary Completion Date

December 31, 2014

Study Completion Date

December 31, 2014

Conditions
Acute Kidney Injury
Interventions
DRUG

Sildenafil

"The active study drug, Revatio®, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type-5 (PDE5). Sildenafil citrate is designated chemically as 1-\[\[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo \[4,3-d\] pyrimidin-5-yl)-4-ethoxyphenyl\] sulfonyl\]-4-methylpiperazine citrate.~The active study medication is supplied in single use glass vials and as a clear, colourless, sterile, ready-to-use solution containing 10 mg (12.5 mL) of sildenafil. Each mL of solution contains 1.124 mg sildenafil citrate, 50.5 mg dextrose and water for injection.~Sildenafil is manufactured under Good Manufacturing Practice (EU-GMP) by Pfizer Inc"

Trial Locations (1)

LE3 9QP

Department of Cardiovascular Sciences., Leicester

All Listed Sponsors
collaborator

British Heart Foundation

OTHER

lead

University of Leicester

OTHER

NCT02136329 - A Study to Determine the Pharmacokinetic Profile, Safety and Tolerability of Sildenafil (REVATIO®) in Cardiac Surgery | Biotech Hunter | Biotech Hunter