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

NCT02136329 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2020-01-30

No results posted yet for this study

Summary

The objectives of the study are the following:

* To evaluate the pharmacokinetic profile of Sildenafil in cardiac surgery patients at risk of acute kidney injury
* To determine the safety and tolerability of Sildenafil in cardiac surgery patients at risk of acute kidney injury

Conditions

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

Sponsors & Collaborators

  • British Heart Foundation

    collaborator OTHER

  • University of Leicester

    lead OTHER

Principal Investigators

  • Gavin Murphy, Prof · University of Leicester

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02136329 on ClinicalTrials.gov