Vardenafil Orodispersible Tablet (ODT) Versus Placebo in Males With Erectile Dysfunction, 50% of Whom Are to be 65 Years or Older.
Information source: Bayer
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Erectile Dysfunction
Intervention: Levitra (Vardenafil, BAY38-9456) (Drug); Placebo ODT (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
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.
Clinical Details
Official title: Pivotal Phase III Trial to Investigate the Efficacy and Safety of an Orodispersible Tablet Vardenafil Versus Placebo in the Treatment of Men With Erectile Dysfunction (ED) - a Fixed-Dose, Double-Blind, Randomized Multi-Center Trial
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Positive change in IIEF-EF domain scores. Statistically significant simultaneous change from baseline for both SEP-2, and SEP-3
Secondary outcome: Percentage of subjects achieving "back to normal" erectile function (IIEF-EF > / = 26) at visit 4 (week 12) or LOCF;All diary questions other than SEP 2 and 3 concerning erectile function administered over the entire treatment period; Treatment Satisfaction Scale (TSS) to be administered at the randomization visit and the final visit (or at Premature Discontinuation). A Global Assessment Question (GAQ) concerning the overall effect on erectile function to be administered at the final visit only. Safety laboratory examinations, vital signs, physical examination, ECG, and adverse event monitoring AE monitoring from time of Informed Consent to 48 hours after last tablet (16 or 17 weeks approximately)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
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, 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 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.
Locations and Contacts
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
México, D. F. 06700, Mexico; Recruiting
México D. F. 14000, Mexico; Recruiting
Mesa, Arizona 85203, United States; Completed
Tempe, Arizona 85283, United States; Completed
Phoenix, Arizona 85023, United States; Active, not recruiting
Phoenix, Arizona 85050, United States; Completed
Mesa, Arizona 85201, United States; Completed
Chandler, Arizona 85224, United States; Active, not recruiting
San Diego, California 92101, United States; Completed
National City, California 91950, United States; Active, not recruiting
San Diego, California 92120, United States; Active, not recruiting
Irvine, California 92618-3603, United States; Completed
Pembroke Pines, Florida 33024, United States; Active, not recruiting
Aventura, Florida 33180, United States; Completed
Jacksonville, Florida 32257, United States; Active, not recruiting
Guadalajara, Jalisco 45040, Mexico; Recruiting
Sydney, New South Wales 2065, Australia; Recruiting
Sydney, New South Wales 2022, Australia; Recruiting
New York, New York 10029, United States; Completed
Great Neck, New York 11021, United States; Completed
Columbus, Ohio 43214-1419, United States; Completed
Cincinnati, Ohio 45212-2787, United States; Active, not recruiting
London, Ontario N6A 4V2, Canada; Active, not recruiting
Oakville, Ontario L6H 3P1, Canada; Completed
Toronto, Ontario M4N 3M5, Canada; Not yet recruiting
Toronto, Ontario M4C 5T2, Canada; Not yet recruiting
Levittown, Pennsylvania 19056, United States; Completed
Norristown, Pennsylvania 19401, United States; Completed
Montreal, Quebec H2X 1N8, Canada; Not yet recruiting
Montreal, Quebec H3T 1E2, Canada; Not yet recruiting
Chicoutimi, Quebec G7H 4A3, Canada; Completed
Greenfield Park, Quebec J4V 2H3, Canada; Completed
Adelaide, South Australia 5000, Australia; Recruiting
Melbourne, Victoria 3144, Australia; Recruiting
Spokane, Washington 99202, United States; Completed
Perth, Western Australia 6009, Australia; Recruiting
Mérida, Yucatán 97001, Mexico; Recruiting
Additional Information
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Starting date: April 2008
Ending date: March 2009
Last updated: February 5, 2009
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