Clinical Proof-of-concept Study for the Combination BAY60-4552 / Vardenafil for the Treatment of Erectile Dysfunction Not Sufficiently Responsive to Standard Therapy With PDE5 Inhibitors
NCT ID: NCT01168817
Last Updated: 2014-11-04
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
PHASE2
140 participants
INTERVENTIONAL
2010-08-31
2011-05-31
Brief Summary
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Patients meeting the entry criteria, will receive vardenafil alone in the first four weeks of the study to assess the effect of PDE5 inhibitor therapy given alone.
Patients with an insufficient therapeutic response to vardenafil alone will enter the next part of the study, and will be randomly assigned to one of 3 treatments. There is a 1 in 3 chance of receiving either the combination BAY60-4552 plus vardenafil, or vardenafil alone, or placebo. Neither patient nor the treating physician will know which treatment is given (double-blinded design).This part of the study will last four weeks Patients will have to go to the clinic/hospital for 7 visits during the 8 weeks.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm 1
BAY60-4552 plus Vardenafil
Treatment with 3 tablets once daily for 4 weeks (Vardenafil 10 mg plus BAY60-4552 1.0 mg)
Arm 2
Vardenafil
Treatment with 3 tablets once daily for 4 weeks (Vardenafil 20 mg)
Arm 3
Placebo
Treatment with 3 tablets once daily for 4 weeks (Placebo)
Interventions
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BAY60-4552 plus Vardenafil
Treatment with 3 tablets once daily for 4 weeks (Vardenafil 10 mg plus BAY60-4552 1.0 mg)
Vardenafil
Treatment with 3 tablets once daily for 4 weeks (Vardenafil 20 mg)
Placebo
Treatment with 3 tablets once daily for 4 weeks (Placebo)
Eligibility Criteria
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Inclusion Criteria
* Written informed consent signed before any study-specific procedure
* History of ED (Erectile Dysfunction) for at least 6 months prior to screening, defined as "the inability to achieve and maintain an erection of the penis sufficient to complete satisfactory sexual intercourse"; the diagnosis of ED has to be confirmed by a physician
* Stable, heterosexual relationship for at least 6 months prior to screening
* Aged 18 to 64 years (inclusive) at the first screening examination
* History of previous use of at least 1 marketed PDE5 (Phosphodiesterase 5) inhibitor and insufficient therapeutic efficacy despite use of the highest approved dose
* Double-blind treatment phase (last four weeks):
* At least 4 attempts at sexual intercourse on 4 separate days during the open-label run-in phase with use of 20 mg vardenafil approximately 1 hour before attempting intercourse
* IIEF EF (International Index of Erectile Function - Erectile Function subscale) score \<17
* At least 50% of attempts at sexual intercourse during the open-label run-in phase were unsuccessful
Exclusion Criteria
* History of prostatectomy due to prostate cancer, including nerve-sparing techniques.
* Concomitant use of adrenergic blockers
* History of spinal cord injury
* Resting hypotension, i.e. SBP (Systolic Blood Pressure) \<100 mmHg at rest
* Moderate / severe hypertension, i.e. SBP \>170 mmHg or DBP \>110 mmHg at rest
* Symptomatic orthostatic hypotension with a decrease in SBP \>20 mmHg or in DBP (Diastolic Blood Pressure) \>10 mmHg subsequent to change from the supine to standing position
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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Oulu, , Finland
Tampere, , Finland
Turku, , Finland
Chambéry, , France
Garches, , France
Lille, , France
Lyon, , France
Nice, , France
Nîmes, , France
Weiden, Bavaria, Germany
Hamburg, City state of Hamburg, Germany
Hamburg, City state of Hamburg, Germany
Marburg, Hesse, Germany
Osnabrück, Lower Saxony, Germany
Mülheim, North Rhine-Westphalia, Germany
Koblenz, Rhineland-Palatinate, Germany
Leipzig, Saxony, Germany
Leipzig, Saxony, Germany
Florence, , Italy
Milan, , Italy
Napoli, , Italy
Roma, , Italy
Groningen, Provincie Groningen, Netherlands
Leiden, , Netherlands
The Hague, , Netherlands
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Aravaca, Madrid, Spain
Majadahonda, Madrid, Spain
Málaga, Málaga, Spain
Eskilstuna, , Sweden
Gothenburg, , Sweden
Halmstad, , Sweden
Jönköping, , Sweden
Linköping, , Sweden
Stockholm, , Sweden
Countries
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Related Links
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Click here and search for information of Bayer products for Europe
Other Identifiers
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2010-020122-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
14694
Identifier Type: -
Identifier Source: org_study_id
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