The Safety of Vardenafil in Patients Undergoing Cardiac Surgery

This study has been completed.
Sponsor:
Information provided by:
McGuire Research Institute
ClinicalTrials.gov Identifier:
NCT01260285
First received: December 10, 2010
Last updated: November 2, 2011
Last verified: November 2011

December 10, 2010
November 2, 2011
December 2010
October 2011   (final data collection date for primary outcome measure)
Hypotension [ Time Frame: approximately 5 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01260285 on ClinicalTrials.gov Archive Site
Ejection Fraction [ Time Frame: approximately 5-7 days postop ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Safety of Vardenafil in Patients Undergoing Cardiac Surgery
The Safety of Vardenafil in Patients Undergoing Cardiac Surgery

The purpose of this study is to evaluate the safety of vardenafil in cardiac surgery patients.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Ischemia-reperfusion Injury.
Drug: Vardenafil
10 mg PO once
Experimental: Vardenafil
Intervention: Drug: Vardenafil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
October 2011
October 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • undergoing cardiac surgery

Exclusion Criteria:

  • emergent surgery
  • recent MI in past 7 days prior to surgery
  • ejection fraction < 35%
  • creatinine > 2.0
  • prior CVA
  • severe COPD
  • recent use of nitrates (within past 48 hours prior to surgery)
  • prior CABG
  • pregnancy
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01260285
01703
No
Dr. Ion Jovin, MD, McGuire VAMC
McGuire Research Institute
Not Provided
Principal Investigator: Ion Jovin, MD McGuire VAMC
McGuire Research Institute
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP