Assessment of Efficacy of Vardenafil in the Treatment of Subjects With Symptomatic Benign Prostatic Hyperplasia
Information source: Bayer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Benign Prostatic Hyperplasia
Intervention: Levitra (Vardenafil, BAY38-9456) (Drug); Placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
Summary
Assessment of efficacy of vardenafil in the treatment of subjects with symptomatic Benign
Prostatic Hyperplasia
Clinical Details
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel Group Study to Assess the Efficacy of Vardenafil in the Treatment of Subjects With Symptomatic Benign Prostatic Hyperplasia
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: International Prostate Symptom Score and maximal urinary flow
Secondary outcome: International Prostate Symptom Score, storing and voiding subscoreIIEF-EF domains score Safety nad tolerability
Detailed description:
The purpose of this study is to find out whether vardenafil can improve the lower urinary
tract symptoms of benign prostatic hyperplasia after 8 weeks of daily administration of 10 mg
BID.
Eligibility
Minimum age: 45 Years.
Maximum age: 64 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Males 45 to 64 years of age
- Lower urinary tract symptoms > 6 months
- International Prostate Symptom Score > 12
Exclusion Criteria:
- Prostate Specific Antigen > 3 ng/ml
- Residual urine volume > 150 ml
- History of myocardial infarction, stroke or life-threatening arrhythmia within the
prior 6 months
- Nitrate use
- Other exclusion criteria apply acc. to Summary of Product Characteristics
Locations and Contacts
Biberach, Baden-Württemberg / 277 88400, Germany
Weiden, Bayern / 280 92637, Germany
München, Bayern / 280 81925, Germany
Starnberg, Bayern / 280 82319, Germany
Rosenheim, Bayern / 280 83022, Germany
Hamburg, Hamburg / 287 20354, Germany
Hamburg, Hamburg / 287 20251, Germany
Marburg, Hessen / 307 35039, Germany
Tostedt, Niedersachsen / 292 21255, Germany
Osnabrück, Niedersachsen / 293 49076, Germany
Düsseldorf, Nordrhein-Westfalen / 296 40210, Germany
Leverkusen, Nordrhein-Westfalen / 331 51373, Germany
Mülheim, Nordrhein-Westfalen / 619 45468, Germany
Leipzig, Sachsen / 313 04105, Germany
Kiel, Schleswig-Holstein / 306 24105, Germany
Additional Information
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Starting date: October 2005
Ending date: June 2006
Last updated: April 9, 2008
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