Vardenafil Orodispersible Tablet (ODT) Versus Placebo in Males With Erectile Dysfunction, 50% of Whom Are to be 65 Years or Older.

Inclusion Criteria:

• 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 Criteria:

• Any underlying cardiovascular condition, including unstable angina pectoris

• History of myocardial infarction, stroke or life-threatening arrhythmia within 6months 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 opticneuropathy), 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, itraconazoleor ketoconazole, and clarithromycin and erythromycin.

• Subjects taking medication known to prolong QT interval, such as Type Ia and Type 3anti-arrhythmics.

• Subjects who have been confirmed with phenylketonuria (PKU).

• Use of any treatment for ED within 7 days of Visit 1.