Assessment of Efficacy of Vardenafil in the Treatment of Subjects With Symptomatic Benign Prostatic Hyperplasia
NCT ID: NCT00657839
Last Updated: 2014-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
222 participants
INTERVENTIONAL
2005-10-31
2006-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm 1
Levitra (Vardenafil, BAY38-9456)
10 mg Vardenafil bid
Arm 2
Placebo
Matching placebo
Interventions
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Levitra (Vardenafil, BAY38-9456)
10 mg Vardenafil bid
Placebo
Matching placebo
Eligibility Criteria
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Inclusion Criteria
* Lower urinary tract symptoms \> 6 months
* International Prostate Symptom Score \> 12
Exclusion Criteria
* Residual urine volume \> 150 m
* History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months
* Nitrate use
45 Years
64 Years
MALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Biberach, Baden-Württemberg / 277, Germany
München, Bayern / 280, Germany
Rosenheim, Bayern / 280, Germany
Starnberg, Bayern / 280, Germany
Weiden, Bayern / 280, Germany
Hamburg, Hamburg / 287, Germany
Hamburg, Hamburg / 287, Germany
Marburg, Hessen / 307, Germany
Tostedt, Niedersachsen / 292, Germany
Osnabrück, Niedersachsen / 293, Germany
Düsseldorf, Nordrhein-Westfalen / 296, Germany
Leverkusen, Nordrhein-Westfalen / 331, Germany
Mülheim, Nordrhein-Westfalen / 481, Germany
Leipzig, Sachsen / 313, Germany
Kiel, Schleswig-Holstein / 306, Germany
Countries
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Related Links
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Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Other Identifiers
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EudraCT No. 2005-002796-32
Identifier Type: -
Identifier Source: secondary_id
11863
Identifier Type: -
Identifier Source: org_study_id
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