Multiple Dose Escalation Study (14 Days) to Investigate Safety, Tolerability, PK and PD of Vardenafil and BAY60-4552
NCT ID: NCT01110590
Last Updated: 2013-02-22
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
PHASE1
37 participants
INTERVENTIONAL
2010-01-31
2010-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
QUADRUPLE
Study Groups
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Arm 1
BAY60-4552 + Vardenafil
Total dose given over 14 days: 5.25 mg BAY60-4552 + 140 mg Vardenafil
Arm 2
BAY60-4552 + Vardenafil
Total dose given over 14 days: 21.0 mg BAY60-4552 + 140 mg Vardenafil
Arm 3
BAY60-4552 + Vardenafil
Total dose given over 14 days: 21.0 mg BAY60-4552 + 280 mg Vardenafil
Arm 4
Placebo
Placebo
Interventions
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BAY60-4552 + Vardenafil
Total dose given over 14 days: 5.25 mg BAY60-4552 + 140 mg Vardenafil
BAY60-4552 + Vardenafil
Total dose given over 14 days: 21.0 mg BAY60-4552 + 140 mg Vardenafil
BAY60-4552 + Vardenafil
Total dose given over 14 days: 21.0 mg BAY60-4552 + 280 mg Vardenafil
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* Male patients with a history of erectile dysfunction (ED) for at least 6 months, defined as "the inability to achieve and maintain an erection of the penis sufficient to complete satisfactory sexual intercourse" by the NIH consensus report 1993. The diagnosis of 'Erectile dysfunction' has to be confirmed by a physician
* Age: 18 to 70 years (inclusive) at the first screening examination
* Ethnicity: White
* Body mass index (BMI): equal to or above 18 and below 32 kg / m²
* Confirmation of the patient's health insurance coverage prior to the first screening examination / visit
* Ability to understand and follow study-related instructions
Exclusion Criteria
* Known hypersensitivity to the study drugs (active substances or excipients of the preparations)
* Known severe allergies, non-allergic drug reactions, or multiple drug allergies
* Any underlying cardiovascular condition, including unstable angina pectoris that would preclude sexual activity according to the NIH consensus report 1993
* History of myocardial infarction, stroke or life-threatening arrhythmia within 6 months prior to screening
* Bleeding disorder
* History of prostatectomy because of prostate cancer, including nerve-sparing techniques. Clarification: Any surgical procedures for the treatment of Benign Prostate Hypertrophy (BPH) are permitted, with the exception of cryosurgery, cryotherapy or cryoablation
* Hereditary degenerative retinal disorders such as retinitis pigmentosa
* History of loss of vision because of NAION (Bayer Study 12912), temporary or permanent loss of vision, including unilateral loss of vision
* History of uni- or bilateral hearing loss
18 Years
70 Years
MALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Bayer HealthCare AG
Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Mönchengladbach, North Rhine-Westphalia, Germany
Countries
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Other Identifiers
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2009-015894-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
14612
Identifier Type: -
Identifier Source: org_study_id
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