BAY38-9456 (Vardenafil HCL Tablet) in ED Treatment for China Registration.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00668057
First received: April 24, 2008
Last updated: October 9, 2013
Last verified: October 2013

April 24, 2008
October 9, 2013
December 2002
September 2003   (final data collection date for primary outcome measure)
Erectile Function domain score of the International Index of Erectile Function, questions 1-5 and 15 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00668057 on ClinicalTrials.gov Archive Site
  • Global Assessment Questionnaire [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Erectile Function domain score of the International Index of Erectile Function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
BAY38-9456 (Vardenafil HCL Tablet) in ED Treatment for China Registration.
Randomized, Double-blind, Multi-centre, Parallel-goup Study to Investigate the Efficacy and Safety of Three Doses of BAY38-9456 (5 mg, 10 mg and 20 mg) Versus Placebo in the Treatment of Patients With Erectile Dysfunction

This study was to compare the efficacy of 3 doses of vardenafil, 5 mg, 10 mg and 20 mg, with matching placebo in Chinese male ED patients, treated for a maximum of 12 weeks.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Erectile Dysfunction
  • Drug: Levitra (Vardenafil, BAY38-9456)
    5 mg Vardenafil orally 1 hour prior to sexual intercourse
  • Drug: Levitra (Vardenafil, BAY38-9456)
    10 mg Vardenafil orally 1 hour prior to sexual intercourse
  • Drug: Levitra (Vardenafil, BAY38-9456)
    20 mg Vardenafil orally 1 hour prior to sexual intercourse
  • Drug: Placebo
    5 mg matching placebo
  • Drug: Placebo
    10 mg matching placebo
  • Drug: Placebo
    20 mg matching placebo
  • Experimental: Arm 1
    Intervention: Drug: Levitra (Vardenafil, BAY38-9456)
  • Experimental: Arm 2
    Intervention: Drug: Levitra (Vardenafil, BAY38-9456)
  • Experimental: Arm 3
    Intervention: Drug: Levitra (Vardenafil, BAY38-9456)
  • Placebo Comparator: Arm 4
    Intervention: Drug: Placebo
  • Placebo Comparator: Arm 5
    Intervention: Drug: Placebo
  • Placebo Comparator: Arm 6
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
480
September 2003
September 2003   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Men with ED for more than 6 months. ED defined according to the National Institute of Health, USA Department of Health and Human Services, consensus statement, as the inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance.
  • Stable heterosexual relationship

Exclusion Criteria:

  • Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the 6-month period prior to Visit 1 (Week -4)
  • Nitrate use
  • Other exclusion criteria apply
Male
22 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00668057
10690
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP