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To assess changes with respect to Erectile Dysfunction in subjects treated with Viagra and antihypertensive therapy.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sildenafil Citrate | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy measure is the percent of ITT subjects at week 8 with positive response to the Global Efficacy Assessment question regarding the effectiveness of the medication in improving erections over no treatment at all for ED. |
| Measure | Description | Time Frame |
|---|---|---|
| The evaluation of change from baseline to week 8 on the toal SHI-M (Sexual Health Inventory-Male) score and the 5 individual items on the SHI-M. Global Efficacy Assessment Questions 2 and 3 at week 8. |
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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 | Torreón | Coahuila | 72000 | Mexico | ||
| Pfizer Investigational Site |
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| Guadalajara |
| Jalisco |
| 44290 |
| Mexico |
| Pfizer Investigational Site | Colonia Centro | Mexico City | 06090 | Mexico |
| Pfizer Investigational Site | DF | Mexico City | 06760 | Mexico |
| Pfizer Investigational Site | Mexico City | Mexico City | 07760 | Mexico |
| Pfizer Investigational Site | Monterrey | Nuevo León | 64000 | Mexico |
| Pfizer Investigational Site | Monterrey | Nuevo León | 64460 | Mexico |
| Pfizer Investigational Site | San Luis PotosÃ- | San Luis PotosÃ- | 78240 | Mexico |
| Pfizer Investigational Site | Mérida | Yucatán | 97070 | Mexico |
| Pfizer Investigational Site | Aguascalientes | C.P. 20230 | Mexico |
| Pfizer Investigational Site | Chihuahua City | 31238 | Mexico |
| Pfizer Investigational Site | Durango | 34300 | Mexico |
| Pfizer Investigational Site | Metepec | 52140 | Mexico |
| Pfizer Investigational Site | Puebla City | 72090 | Mexico |
| Pfizer Investigational Site | San Luis Potosí City | 78090 | Mexico |
| Pfizer Investigational Site | Veracruz | C.P. 97897 | Mexico |
| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000068677 | Sildenafil Citrate |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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