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

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ClinicalTrials.gov Identifier: NCT00668005
Recruitment Status : Completed
First Posted : April 28, 2008
Last Update Posted : December 16, 2014
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Bayer

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

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Drug: Levitra (Vardenafil, BAY38-9456) Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 388 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2003
Actual Study Completion Date : September 2003


Arm Intervention/treatment
Experimental: Arm 1 Drug: Levitra (Vardenafil, BAY38-9456)
5mg, 10mg or 20mg taken 1h before sexual intercourse
Placebo Comparator: Arm 2 Drug: Placebo
Matching placebo



Primary Outcome Measures :
  1. Sexual Encounter Profile (SEP), questions 2 and 3 [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. International Index of Erectile Function (IIEF) - EF (Erectile Function) domain [ Time Frame: 12 weeks ]
  2. Global Assessment Questionnaire (GAQ) [ Time Frame: 12 weeks ]
  3. Safety and tolerability [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00668005


Sponsors and Collaborators
Bayer
GlaxoSmithKline
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00668005     History of Changes
Other Study ID Numbers: 100539
First Posted: April 28, 2008    Key Record Dates
Last Update Posted: December 16, 2014
Last Verified: December 2014

Keywords provided by Bayer:
Erectile Dysfunction
Arterial hypertension
Vardenafil

Additional relevant MeSH terms:
Hypertension
Erectile Dysfunction
Vascular Diseases
Cardiovascular Diseases
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Vardenafil Dihydrochloride
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents