Status:
COMPLETED
Vardenafil Orodispersible Tablet (ODT) Versus Placebo in Males With Erectile Dysfunction, 50% of Whom Are to be 65 Years or Older.
Lead Sponsor:
Bayer
Collaborating Sponsors:
GlaxoSmithKline
Schering-Plough
Conditions:
Erectile Dysfunction
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
This study investigates the safety and efficacy of a new dosage form of Vardenafil, an orodispersible tablet (ODT), and compares it to the safety and efficacy of a placebo (inactive) tablet in the tre...
Eligibility Criteria
Inclusion
- Males 18 years-of-age or older.
- Stable, heterosexual relationship for at least 6 months.
- A history of erectile dysfunction (ED) for at least 6 months
Exclusion
- Any underlying cardiovascular condition, including unstable angina pectoris
- History of myocardial infarction, stroke or life-threatening arrhythmia within 6 months prior to visit 1
- Uncontrolled atrial fibrillation / flutter at screening
- History of congenital QT prolongation
- History of surgical prostatectomy due to prostate cancer
- Hereditary degenerative retinal disorders
- History of loss of vision because of NAION (Non-arteritic anterior ischemic optic neuropathy), temporary or permanent loss of vision
- Presence of penile anatomical abnormalities
- Spinal cord injury
- Resting or postural hypotension or hypertension
- Subjects who are taking nitrates or nitric oxide donors, androgens, anti-androgens, alpha-blockers, HIV (Human immunodeficiency virus) protease inhibitors, itraconazole or ketoconazole, and clarithromycin and erythromycin.
- Subjects taking medication known to prolong QT interval, such as Type Ia and Type 3 anti-arrhythmics.
- Subjects who have been confirmed with phenylketonuria (PKU).
- Use of any treatment for ED within 7 days of Visit 1.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
339 Patients enrolled
Trial Details
Trial ID
NCT00655629
Start Date
April 1 2008
End Date
February 1 2009
Last Update
August 1 2014
Active Locations (40)
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1
East Valley Family Physicians, PLC
Chandler, Arizona, United States, 85224
2
Mesa Family Medical Center
Mesa, Arizona, United States, 85203
3
Desert Clinical Research
Mesa, Arizona, United States, 85213
4
Arizona Research Center, Inc.
Phoenix, Arizona, United States, 85023