Status:
COMPLETED
Vardenafil ODT Versus Placebo in Males With Erectile Dysfunction
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 surgical prostatectomy for prostate cancer
- Hereditary degenerative retinal disorders
- History of loss of vision because of Non-arteritic anterior ischemic optic neuropathy (NAION), temporary or permanent loss of vision
- Presence of penile anatomical abnormalities
- Subjects who have been confirmed with phenylketonuria (PKU)
- Spinal cord injury
- Resting or postural hypotension or hypertension
- Subjects who are taking nitrates or nitric oxide donors, androgens, anti-androgens, alpha- blockers, medication known to prolong QT interval, Human immunodeficiency virus (HIV) protease inhibitors, itraconazole or ketoconazole, an clarithromycin and erythromycin
- Use of any treatment for ED within 7 days of Visit 1
- History of congenital QT prolongation
- History of syncope within the last 6 months prior to entry into the study
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
362 Patients enrolled
Trial Details
Trial ID
NCT00631969
Start Date
April 1 2008
End Date
January 1 2009
Last Update
December 30 2014
Active Locations (47)
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1
Antwerp, Belgium, 2020
2
Bruxelles - Brussel, Belgium, 1000
3
Bruxelles - Brussel, Belgium, 1070
4
Bruxelles - Brussel, Belgium, 1200