Evaluating the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction and Hypertension

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00668005
First received: April 24, 2008
Last updated: June 16, 2009
Last verified: June 2009

April 24, 2008
June 16, 2009
February 2003
Not Provided
Sexual Encounter Profile (SEP), questions 2 and 3 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00668005 on ClinicalTrials.gov Archive Site
  • International Index of Erectile Function (IIEF) - EF (Erectile Function) domain [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Global Assessment Questionnaire (GAQ) [ 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
 
Evaluating the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction and Hypertension
A Randomized, Double-Blind, Parallel-Group, Plac-Controlled Study Evaluating the Efficacy and Safety of Vardenafil Administration for 12 Weeks in a Flexible-Dose Regimen Compared to Placebo in Men With Arterial Hypertension and Erectile Dysfunction

Assess efficacy of Vardenafil in patients erectile dysfunction and high blood pressure

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)
    5mg, 10mg or 20mg taken 1h before sexual intercourse
  • Drug: Placebo
    Matching placebo
  • Experimental: Arm 1
    Intervention: Drug: Levitra (Vardenafil, BAY38-9456)
  • Placebo Comparator: Arm 2
    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
430
September 2003
Not Provided

Inclusion Criteria:

  • Men >/= 18 years of age, with 6 months or longer diagnosis of ED as defined by NIH Consensus statement,
  • Arterial hypertension adequately controlled
  • Stable sexual relationship for > 6 month

Exclusion Criteria:

  • Primary hypoactive sexual desire
  • History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
  • Nitrate therapy
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00668005
100539
No
Therapeutic Area Head, Bayer Healthcare AG
Bayer
GlaxoSmithKline
Study Director: Bayer Study Director Bayer
Bayer
June 2009

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