Status:

COMPLETED

Assessment of Efficacy of Vardenafil in the Treatment of Subjects With Symptomatic Benign Prostatic Hyperplasia

Lead Sponsor:

Bayer

Conditions:

Benign Prostatic Hyperplasia

Eligibility:

MALE

45-64 years

Phase:

PHASE2

Brief Summary

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 urinar...

Eligibility Criteria

Inclusion

  • Males 45 to 64 years of age
  • Lower urinary tract symptoms \> 6 months
  • International Prostate Symptom Score \> 12

Exclusion

  • Prostate Specific Antigen \> 3 ng/ml
  • Residual urine volume \> 150 m
  • 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

Key Trial Info

Start Date :

October 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2006

Estimated Enrollment :

222 Patients enrolled

Trial Details

Trial ID

NCT00657839

Start Date

October 1 2005

End Date

June 1 2006

Last Update

October 28 2014

Active Locations (15)

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Page 1 of 4 (15 locations)

1

Biberach, Baden-Württemberg / 277, Germany, 88400

2

München, Bayern / 280, Germany, 81925

3

Rosenheim, Bayern / 280, Germany, 83022

4

Starnberg, Bayern / 280, Germany, 82319