Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00004050

Trial Description

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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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00004050
  •   2012/07/24
  •   2008/04/09
  •   no
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Secondary IDs

  •   2005-002796-32 
  •   NCT00657839  (ClinicalTrials.gov)
  •   11863  (Bayer)
  •   EudraCT No. 2005-002796-32 
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Health Condition or Problem studied

  •   Benign Prostatic Hyperplasia
  •   N40 -  Hyperplasia of prostate
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Interventions/Observational Groups

  •   Drug: Levitra (Vardenafil, BAY38-9456)
  •   Drug: Placebo
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Placebo
  •   Treatment
  •   Parallel
  •   II
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Primary Outcome

- International Prostate Symptom Score and maximal urinary flow; time frame: 8 weeks

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Secondary Outcome

- International Prostate Symptom Score, storing and voiding subscore; time frame: 8 weeks
- IIEF-EF domains score; time frame: 8 weeks
- Safety and tolerability; time frame: 8 weeks

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

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  •   2005/10/31
  •   222
  •   Multicenter trial
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Inclusion Criteria

  •   Male
  •   45   Years
  •   64   Years
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Additional Inclusion Criteria

- Males 45 to 64 years of age

- Lower urinary tract symptoms > 6 months

- International Prostate Symptom Score > 12

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Exclusion Criteria

- 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

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Addresses

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    • Bayer
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    • Bayer
    • Bayer Study Director 
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    • Bayer
    • Bayer Study Director 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up complete
  •   2006/06/01
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Additional Trial Attributes

  • Urological disease 
  • If other, please specify 
  • Study recommendations 
  • If other, please specify 
  • German director of clinical investigation 
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    • [---]*
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  • Further contact 
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  • Function of contact 
  • Non-interventional study 
  • Stage 
  • If other, please specify 
  • Onset of therapy 
  • If other, please specify 
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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   5
  •   2016/01/14
* This entry means the parameter is not applicable or has not been set.