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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00657839 |
Assessment of efficacy of vardenafil in the treatment of subjects with symptomatic Benign Prostatic Hyperplasia.
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.
Condition | Intervention | Phase |
---|---|---|
Benign Prostatic Hyperplasia |
Drug: Levitra (Vardenafil, BAY38-9456) Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Enrollment: | 222 |
Study Start Date: | October 2005 |
Study Completion Date: | June 2006 |
Arms | Assigned Interventions |
---|---|
Arm 1: Experimental |
Drug: Levitra (Vardenafil, BAY38-9456)
10 mg Vardenafil bid
|
Arm 2: Placebo Comparator |
Drug: Placebo
Matching placebo
|
Ages Eligible for Study: | 45 Years to 64 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany, Baden-Württemberg / 277 | |
Biberach, Baden-Württemberg / 277, Germany, 88400 | |
Germany, Bayern / 280 | |
Weiden, Bayern / 280, Germany, 92637 | |
München, Bayern / 280, Germany, 81925 | |
Starnberg, Bayern / 280, Germany, 82319 | |
Rosenheim, Bayern / 280, Germany, 83022 | |
Germany, Hamburg / 287 | |
Hamburg, Hamburg / 287, Germany, 20354 | |
Hamburg, Hamburg / 287, Germany, 20251 | |
Germany, Hessen / 307 | |
Marburg, Hessen / 307, Germany, 35039 | |
Germany, Niedersachsen / 292 | |
Tostedt, Niedersachsen / 292, Germany, 21255 | |
Germany, Niedersachsen / 293 | |
Osnabrück, Niedersachsen / 293, Germany, 49076 | |
Germany, Nordrhein-Westfalen / 296 | |
Düsseldorf, Nordrhein-Westfalen / 296, Germany, 40210 | |
Germany, Nordrhein-Westfalen / 331 | |
Leverkusen, Nordrhein-Westfalen / 331, Germany, 51373 | |
Germany, Nordrhein-Westfalen / 481 | |
Mülheim, Nordrhein-Westfalen / 481, Germany, 45468 | |
Germany, Sachsen / 313 | |
Leipzig, Sachsen / 313, Germany, 04105 | |
Germany, Schleswig-Holstein / 306 | |
Kiel, Schleswig-Holstein / 306, Germany, 24105 |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer Vital GmbH ( Therapeutic Area Head ) |
Study ID Numbers: | 11863, EudraCT No. 2005-002796-32 |
Study First Received: | April 9, 2008 |
Last Updated: | November 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00657839 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Benign Prostate Hyperplasia Vardenafil Genital Disease Male: Signs and symptoms of Benign Prostate Hyperplasia |
Signs and Symptoms Hyperplasia Vardenafil |
Prostatic Diseases Prostatic Hyperplasia Genital Diseases, Male |
Phosphodiesterase Inhibitors Pathologic Processes Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Pharmacologic Actions |