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

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: Male

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 treatment of erectile dysfunction. After a 4-week unmedicated phase, patients will receive Vardenafil ODT or matching placebo for 12 weeks. Safety will be determined by laboratory and other evaluations. Efficacy will be determined by the results of different questionnaires and the patient diary that will be used.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Collaborators: GlaxoSmithKline; Schering-Plough
• Treatments: Vardenafil Dihydrochloride

Criteria

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 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.