Multiple Dose Escalation Study (14 Days) to Investigate Safety, Tolerability, PK and PD of Vardenafil and BAY60-4552

Study Overview
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Brief Summary
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Safety, tolerability, pharmacokinetics and pharmacodynamics will be investigated in this multiple dose escalation study. In three treatments groups different dosages of BAY 60-4552 and vardenafil will be given with patients with erectile dysfunction.

Official Title
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Randomized, Double-blind, Placebo-controlled, Group-comparison, Dose-escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Co-administration of Different Doses of Vardenafil (2 Dose Strengths) and BAY60-4552 (4 Dose Strengths) Given Once-daily (od) Over 14 Days in Patients With Erectile Dysfunction (ED).

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Drug: BAY60-4552 + Vardenafil
* Drug: BAY60-4552 + Vardenafil
* Drug: BAY60-4552 + Vardenafil
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The informed consent must be signed before any study specific tests or procedures are done 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: Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: BAY60-4552 + Vardenafil<br>* Total dose given over 14 days: 5.25 mg BAY60-4552 + 140 mg Vardenafil<br>|
| Experimental: Arm 2<br> | Drug: BAY60-4552 + Vardenafil<br>* Total dose given over 14 days: 21.0 mg BAY60-4552 + 140 mg Vardenafil<br>|
| Experimental: Arm 3<br> | Drug: BAY60-4552 + Vardenafil<br>* Total dose given over 14 days: 21.0 mg BAY60-4552 + 280 mg Vardenafil<br>|
| Placebo Comparator: Arm 4<br> | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Event reporting |  | up to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration of study drugs; Pharmacokinetic parameters: AUC, Cmax, AUC/D, Cmax;norm, Cmax/D, t1/2, tmax |  | Day 0, 6, 13 | 
| Plasma concentration of cyclic guanosine monophosphate (cGMP) |  | Day 0, 6, 13 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erectile Dysfunction