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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-015894-11 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Experimental |
| |
| Arm 3 | Experimental |
| |
| Arm 4 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY60-4552 + Vardenafil | Drug | Total dose given over 14 days: 5.25 mg BAY60-4552 + 140 mg Vardenafil |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event reporting | up to 6 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mönchengladbach | North Rhine-Westphalia | 41061 | Germany |
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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| ID | Term |
|---|---|
| C569640 | BAY 60-4552 |
| D000069058 | Vardenafil Dihydrochloride |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| BAY60-4552 + Vardenafil | Drug | Total dose given over 14 days: 21.0 mg BAY60-4552 + 140 mg Vardenafil |
|
| BAY60-4552 + Vardenafil | Drug | Total dose given over 14 days: 21.0 mg BAY60-4552 + 280 mg Vardenafil |
|
| Placebo | Drug | Placebo |
|
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D010879 |
| Piperazines |