Assess Efficacy in Subjects With Traumatic Spinal Cord Injury
NCT ID: NCT00667966
Last Updated: 2015-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
45 participants
INTERVENTIONAL
2005-07-31
2007-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Vardenafil + Placebo
Subjects received single dose of 10 mg vardenafil followed by 20 mg vardenafil and then crossed over to 10 mg placebo followed by 20 mg placebo.
Vardenafil (Levitra, BAY 38-9456), 10 mg
10 mg vardenafil was administered with a glass of water 1 h before starting the test with the stimulator.
Placebo
10/20 mg placebo in sequence in respective arm
Vardenafil (Levitra, BAY 38-9456), 20 mg
20 mg vardenafil was administered with a glass of water 1 h before starting the test with the stimulator.
Placebo + Vardenafil
Subjects received single dose of 10 mg placebo followed by 20 mg placebo and then crossed over to 10 mg vardenafil followed by 20 mg vardenafil.
Vardenafil (Levitra, BAY 38-9456), 10 mg
10 mg vardenafil was administered with a glass of water 1 h before starting the test with the stimulator.
Placebo
10/20 mg placebo in sequence in respective arm
Vardenafil (Levitra, BAY 38-9456), 20 mg
20 mg vardenafil was administered with a glass of water 1 h before starting the test with the stimulator.
Interventions
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Vardenafil (Levitra, BAY 38-9456), 10 mg
10 mg vardenafil was administered with a glass of water 1 h before starting the test with the stimulator.
Placebo
10/20 mg placebo in sequence in respective arm
Vardenafil (Levitra, BAY 38-9456), 20 mg
20 mg vardenafil was administered with a glass of water 1 h before starting the test with the stimulator.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
* Nitrate therapy
18 Years
64 Years
MALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Badalona, Barcelona, Spain
Toledo, Toledo, Spain
Countries
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Related Links
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Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Other Identifiers
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2004-005282-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
11861
Identifier Type: -
Identifier Source: org_study_id