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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
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Sexual Encounter Profile (SEP), questions 2 and 3 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 430
Study Start Date: February 2003
Study Completion Date: September 2003
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00668005

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

Additional Information:
No publications provided

Responsible Party: Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT00668005     History of Changes
Other Study ID Numbers: 100539
Study First Received: April 24, 2008
Last Updated: June 16, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Erectile Dysfunction
Arterial hypertension
Vardenafil

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

ClinicalTrials.gov processed this record on November 25, 2014