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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00668005
First Posted: April 28, 2008
Last Update Posted: December 16, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Bayer
April 24, 2008
April 28, 2008
December 16, 2014
February 2003
Not Provided
Sexual Encounter Profile (SEP), questions 2 and 3 [ Time Frame: 12 weeks ]
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 ]
  • Global Assessment Questionnaire (GAQ) [ Time Frame: 12 weeks ]
  • Safety and tolerability [ Time Frame: 12 weeks ]
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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
388
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
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00668005
100539
No
Not Provided
Not Provided
Bayer
Bayer
GlaxoSmithKline
Study Director: Bayer Study Director Bayer
Bayer
December 2014

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