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This is a 12 week study in which different doses and formulations of UK-369,003 will be administered to patients with a diagnosis of enlarged prostate. Patients will complete a series of questionnaires before, during and after treatment to assess if UK-369,003 has improved their urinary symptoms and erectile function . There will be several blood samples taken during the study to asses the level of drug in the blood and correlate it with the responses to the questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Comparator | Active Comparator | Tamsulosin 0.4 mg prolonged release |
|
| Treatment Arm | Experimental | There are 5 possible UK-369,003 arms as follows: UK-369,003 MR (10mg, 25mg, 50mg & 100mg), UK-369,003 IR (40mg), |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamsulosin | Drug | Tamsulosin hydrochloride capsules, 0.4 mg. Tamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in international prostate symptom score | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Erectile Function (EF) domain of International Index of Erectile | 12 weeks | |
| Function (IIEF) | 12 weeks | |
| Qmax |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Herston | Queensland | Australia | |||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| UK-369,003 | Drug | UK 369,003 is a highly selective and potent inhibitor of PDE5. It has increased selectivity for PDE5 over PDE6 (>80 fold) compared to sildenafil (~10 fold). Two recently completed trials have shown efficacy for UK-369,003 in treating subjects with ED |
|
| 12 weeks |
| Quality of Erection questionnaire (QEQ) | 12 weeks |
| Population pharmacokinetics | 12 weeks |
| Adelaide |
| South Australia |
| 5000 |
| Australia |
| Pfizer Investigational Site | Brussels | B-1090 | Belgium |
| Pfizer Investigational Site | Brussels | Belgium |
| Pfizer Investigational Site | Edegem | B-2650 | Belgium |
| Pfizer Investigational Site | Calgary | Alberta | T2V 4R6 | Canada |
| Pfizer Investigational Site | London | Ontario | N6A 4V2 | Canada |
| Pfizer Investigational Site | Pointe-Claire | Quebec | H9R 4S3 | Canada |
| Pfizer Investigational Site | Temuco | Araucania | 4810371 | Chile |
| Pfizer Investigational Site | Santiago | Chile |
| Pfizer Investigational Site | Medellín | Antioquia | 0 | Colombia |
| Pfizer Investigational Site | Barranquilla | Atlántico | 0 | Colombia |
| Pfizer Investigational Site | Bogota | Cundinamarca | 0 | Colombia |
| Pfizer Investigational Site | Bogota | Cundinamarca | Colombia |
| Pfizer Investigational Site | Cali | Valle del Cauca Department | 0 | Colombia |
| Pfizer Investigational Site | Aalborg | 9100 | Denmark |
| Pfizer Investigational Site | Aarhus N | 8200 | Denmark |
| Pfizer Investigational Site | Gentofte Municipality | 2820 | Denmark |
| Pfizer Investigational Site | Helsinki | 00100 | Finland |
| Pfizer Investigational Site | Kuopio | 70100 | Finland |
| Pfizer Investigational Site | Oulu | 90100 | Finland |
| Pfizer Investigational Site | Tampere | 33100 | Finland |
| Pfizer Investigational Site | Larissa | 41110 | Greece |
| Pfizer Investigational Site | Rio | 26500 | Greece |
| Pfizer Investigational Site | Thessaloniki | 56403 | Greece |
| Pfizer Investigational Site | Foggia | 71100 | Italy |
| Pfizer Investigational Site | Siena | 53100 | Italy |
| Pfizer Investigational Site | Riga | LV-1002 | Latvia |
| Pfizer Investigational Site | Kaunas | 47144 | Lithuania |
| Pfizer Investigational Site | Kaunas | 50009 | Lithuania |
| Pfizer Investigational Site | Vilnius | 08661 | Lithuania |
| Pfizer Investigational Site | Bydgoszcz | 85-092 | Poland |
| Pfizer Investigational Site | Bydgoszcz | 85-168 | Poland |
| Pfizer Investigational Site | Gdansk | 80-402 | Poland |
| Pfizer Investigational Site | Gdynia | 81-393 | Poland |
| Pfizer Investigational Site | Mysłowice | 41-400 | Poland |
| Pfizer Investigational Site | Wejherowo | 84-200 | Poland |
| Pfizer Investigational Site | Bratislava | 851 01 | Slovakia |
| Pfizer Investigational Site | Malacky | 901 01 | Slovakia |
| Pfizer Investigational Site | Nitra | 949 01 | Slovakia |
| Pfizer Investigational Site | Prešov | 080 01 | Slovakia |
| Pfizer Investigational Site | Skalica | 909 82 | Slovakia |
| Pfizer Investigational Site | Madrid | 28035 | Spain |
| Pfizer Investigational Site | Málaga | 29010 | Spain |
| Pfizer Investigational Site | Valencia | 46010 | Spain |
| Pfizer Investigational Site | Bristol | BS2 8HW | United Kingdom |
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077409 | Tamsulosin |
| C553931 | 1-(6-ethoxy-5-(3-ethyl-6,7-dihydro-2-(2-methoxyethyl)-7-oxo-2H-pyrazolo(4,3-d)pyrimidin-5-yl)-3-pyridyl sulphonyl)-4-ethylpiperazine |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
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